An Uncontrolled, Single Centre, Healthy Volunteer, Phase II Proof-of-concept Trial Investigating MR-enterography Image Quality of Lumentin® 44, a New Egg Albumen Based Oral Small Bowel Filling Contrast Agent.
Phase: PHASE2
Conditions: Healthy
Sponsor: Lument AB

    
 
 
 
C LI NI C A L T RI A L P R O T O C O L 
 
A n u nc o ntr olle d, si n gle ce ntre, healt h y v ol u nteer, P hase II pr o of- of-c o n ce pt tri al i n vesti gati n g 
M R-e nter o gra p h y i ma ge q u alit y of L u me nti n
®  4 4, a ne w e g g al b u me n base d oral s mall b o wel 
filli n g c o ntrast a g e nt. 
 
S p o ns or si g nat or y: 
Ja n Marsal 
L u me nt A B 
S c heele v ä g e n 2 2 
B o x 7 1 9 
S E- 2 2 0 0 7 L u n d 
S we de n 
 
C o or di n ati n g I n vesti gat or 
Dr. Pet er Le a n der 
R ö nt g e n, Perit us kli ni ke n A B 
S c heele v ä g e n 8 
2 2 3 6 3 L u n d 
S we de n 
 
S p o ns or Pr ot oc ol N o.:  
L U M RI S -0 0 1  
Pr ot o c ol Versi o n  
2 . 0 Fi nal 
E u dra C T N o.: 
2 0 2 2- 0 0 2 1 9 3- 8 4 
Trial  Dr u g Na me:  
L u me nti n ®  4 4  
De vel o p me nt P hase:  
II 
Date of Pr ot oc ol:  
0 9 t h Se pt e m ber  2 0 2 2  
Date of Pre vi o us Pr ot oc ol:  
0 9 t h Se pt e m ber 2 0 2 2  
 
T his d oc u me nt c o nt ai ns c o nfi de ntial i nf or mati o n. T he c o nte nts ma y n ot b e use d, di v ul g e d or 
p u blis he d wit h o ut pri or writte n c o nse nt of L u me nt A B.  
T his i nf or mati o n ca n n ot be use d f or a n y ot her p ur p ose t ha n t he c o n d uct a n d e val uati o n of t he 
cli nical i n vesti gati o n b y t he i n v esti g at or(s), t he re g ulat or y a ut h orities a n d m e m b ers of t h e et hics 
c o m mittees

S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
2 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
1  
P R O T O C O L S Y N O P S I S 
 
Title: 
A n u nc o ntr olle d, si n gle c e ntre, healt h y v ol u nteer, P hase II pr o of- of-c o nce pt 
trial i n vesti gati n g M R-e nter o gra p h y ( M R E) i m a ge q u alit y of L u me nti n®  4 4, 
a n e w e g g al b u me n base d oral s mall b o wel filli n g c o ntrast a ge nt. 
S h ort titl e: 
L u me nti n M R-e nt er o gra p h y P o C trial i n h ealt h y v ol u nt eers 
E u dr a C T 
C o de: 
2 0 2 2- 0 0 2 1 9 3- 8 4 
P h ase of 
d e vel o p m e nt 
P h ase II 
B ac k gr o u n d & 
st u d y r ati o n ale  
L u me nti n ®  4 4 is bei n g d e vel o p e d as a n o v el oral c o ntrast me di u m t o b e us e d 
i n dia g n ostic e xa mi nati o ns of t he a b d o me n. P hase II st u dies ha ve bee n 
perf or me d usi n g c o m p ut e d t o m o gra p h y ( C T) ass ess me nt wit h e nc o ura gi n g 
res ults. If t he sa me pr o d u ct ca n als o b e us e d i n M a g netic Res o na nce-
e nt er o gra p h y ( M R E) it c o ul d be a n a d v a nt a ge f or a ra di ol o gical de part m e nt 
t o o nl y ha n dle a si n gle oral c o ntrast me di u m f or b ot h m o d aliti es, C T a n d 
M RI. I n a d diti o n, a d mi nistrati o n of L u me nti n
®  4 4 has s h o w n fe w si de effects 
a n d ma y be a m ore t olera bl e alter nati v e t o t he oral me dia use d t o da y i n C T 
a n d M RI. T h e c urre nt st u d y ai ms t o e x pl ore if t h e si g nal c haracteristics of 
L u me nti n ®  4 4 is fa v o ura ble i n M R E. 
T his pr o of- of-c o nce pt ( P o C) trial is perf or me d i n healt h y v ol u nteers ( H Vs) 
wit h t he ai m t o s h o w t h at L u me nti n ®  4 4 ca n be use d as a n oral s mall b o wel 
filli n g c o ntrast a g e nt f or M R E.  
Pri m a r y 
o bjecti ve 
 T o e val uate if L u m e nti n ®  4 4 use d as a b o w el filli n g a ge nt i n M R E 
e xa mi nati o n ge n erates i ma ges wit h acce pta bl e di a g n ostic q ualit y. 
S ec o n d ar y 
o bjecti ves 
 
 
 
 
 
 
 T o e val uate pl as m a el ectr ol ytes i ncl u di n g, p otassi u m, s o di u m, p h os p hate, 
a n d calci u m, as w ell as i o nize d calci u m c o nce ntrati o n le vels d uri n g 2 4 
h o urs after i nta ke of L u m e nti n ®  4 4. 
 T o e val uate b o w el filli n g pr o perties (e xte nsi o n a n d diste nsi o n) of 
L u me nti n ®  4 4. 
 T o e val uate t he s afet y a n d t olera bilit y of L u me nti n ®  4 4 i nta ke. 

S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
3 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
 
 
Pri m a r y 
o utc o me 
 
 
 
 Vis u al e val uati o n of t he M R E i ma ges fr o m eac h trial s u bject wit h res pect 
t o m otilit y, artefacts, m u c osal e val uati o n a n d o verall dia g n ostic 
i m pressi o n. 
S ec o n d ar y 
o utc o mes 
 C o nce ntrati o n of plas ma electr ol ytes i n cl u di n g, p otassi u m, s o di u m, 
p h os p h ate, a n d calci u m, as well as i o nize d calci u m i n bl o o d sa m ples 
ta ke n at T 0 h, T 1 h, T 2 h, T 4 h, T 6 h, T 8 h, a n d T 2 4 h. 
 B o wel filli n g pr o perti es (e xt e nsi o n a n d dist e nsi o n) i n eac h of 5 s electe d 
s u b-se g me nts of t he s mall b o wel. 
 A n y treat me nt e mer ge nt a d verse e ve nts ( T E A Es) a n d treat me nt e m er g e nt 
a d verse dr u g reacti o ns ( T E A D Rs). 
I n vesti g ati o n al 
p r o d uct, 
f or m ul ati o n, 
d os a g e a n d 
m o de of 
a d mi nistr ati o n:  
L u me nti n ®  4 4 P o w der f or oral f oa m pr o vi de d i n la belle d w hite sa c hets w hite 
sac hets c o ntai ni n g 1 7. 4 g p o w der. P ota ble w ater (c o m merciall y a v aila ble still 
water 0. 5 L p er b ottle) f or t he pre p arati o n of t h e f oa m will b e use d. 
L u me nti n ® 4 4 p o w der f or oral f oa m will b e d eli vere d fr o m A P L t o t h e 
cli nical site, b y or der vi a t he h os pital p har mac y a n d st ore d te m p oraril y at t h e 
site. T he i n vesti gati o nal pr o d uct ( L u me nti n ® 4 4 f oa m) is t he n pre p are d i n-
sit u b y a d di n g 0. 5 L p ota ble water t o L u me nti n ®  4 4 p o w der c o nt ai n e d i n o ne 
sac het, a n d t he ble n d is t he n mi xe d t o a sta ble f o a m i n a de dicate d 
pre parati o n u nit. T h e fres hl y pre pare d f oa m will be a d mi nistere d t o t he 
patie nt wit hi n 5 t o 1 0 mi n utes. T he i n-sit u pre p arati o n will f oll o w 
a pr oce d ure attac he d t o t he cli nical tri al pr ot oc ol. T he staff res p o nsi ble f or 
t he i n-sit u pre p arati o n will be trai ne d usi n g t h e pr o ce d ure a n d t heir trai ni n g 
d oc u me nte d i n t he Trial Master Fil e.  T w o sac h ets ( 0. 9 L f oa m per sac het) 
will be re q uire d p er s u bject.  
Tri al desi g n 
T his is a n u n c o ntr olle d, si n gle ce ntre p h ase II trial. E nr olle d H Vs ( n = 1 0) will 
u n der g o ga d oli ni u m ( G d) b ase d M R E after oral i nt a k e of L u me nti n ®  4 4. 
I ntereste d H Vs will be i d e ntifie d pri maril y a m o n g me dical st u d e nts at t h e 
me di cal h os pitals at Mal m ö a n d L u n d. P ost ers will b e pl ace d at t he 
de p art me nts a n d i n vit ati o n letters will be ha n de d o ut. 
H Vs i ntereste d i n parti ci pati n g will be i n vite d t o atte n d a pre-scree ni n g visit 
w here t heir s uita bilit y base d o n a ge a n d healt h stat us will b e assess e d. Fift ee n 
H Vs w h o f ulfil t h e pre-scree ni n g criteri a a n d are still i ntereste d i n 
partici p ati n g will be as ke d t o att e n d a s cree ni n g visit at t he cli nic a n d if 

S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
4 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
eli gi ble f or t he trial t he y will t he n visit t h e cli nic f or M R E assess me nt wit hi n 
1- 2 wee ks.   
O nl y t he first 1 0 of t he eli gi ble H Vs will be as k e d t o c o me f or M R E 
e xa mi nati o n a n d t he re m ai ni n g eli gi ble s u bjects will b e as k e d t o sta n d b y i n 
case a n y of t h e 1 0 s u bjects are u n a ble t o c o me or ca n n ot u n der g o t h e 
e xa mi nati o n.  
H Vs will be as ke d t o fast f or 6 h o urs pri or t o t he e xa mi n ati o n o n t he da y of 
t he M R E e xa mi nati o n. Clear li q ui d i n s mall v ol u mes u p t o 2 decilitres is 
all o we d. Pri or t o M R E, L u me nti n ®  4 4 will be pr o vi de d t o t he m i n v ol u mes of 
u p t o 1. 5 L a n d at l east 1. 1 L of L u me nti n ®  4 4 m ust b e dr u n k. T he s u bjects 
will be as ke d t o dri n k t h e s ol uti o ns of oral c o ntrast a ge nt wit hi n 4 5 mi n ut es 
t o 1 h o ur.  
S u bjects n ot a ble t o dri n k at l east 1. 1 L of L u me nti n ®  4 4 will be wit h dra w n 
fr o m t h e tri al. 
Pri or t o t h e i nta ke of L u me nti n ®  4 4, a n i ntra ve n o us (I V) a nt ec u bital c a n n ul a 
will be place d a n d us e d f or bl o o d sa m pli n g a n d a d mi nistrati o n of G d c o ntrast 
a ge nt d uri n g t h e M R E assess me nt.  
Assess me nts  
Scree ni n g assess me nts: H Vs f ulfilli n g t he eli gi bilit y crit eria a n d w h o si g n 
t he c o nse nt t o p artici pate will u n d er g o a p h ysical e xa mi nati o n, p erf or m a 
pre g n a nc y test (fe m al es o nl y) a n d ha ve a creati ni ne bl o o d sa m ple ta ke n. 
Me dical hist or y, de m o gr a p hics, c o nc o mita nt treat me nt a n d ill n esses will als o 
be rec or de d.. 
M R E assess me nt:  M R E will start wit hi n 1 0 mi n utes aft er t he c o ntrast a ge nt 
has bee n dr u n k a n d will last f or a p pr o xi mat el y 4 0 mi n utes. 
T he H V will be br o u g ht t o t he M R E-sca n n er s uit e i nsi d e t h e m a g net usi n g 
t he m o vi n g ta ble a n d sca n ni n g will c o m me nce. All series will b e ta ke n as per 
sta n dar d cli nical M R E pr ot o c ol rec o g nise d b y ra di ol o gists i n E ur o pe a n d 
N ort h A meric a. After d y na mic series ac q uisiti o n, a s pas m ol ytic a ge nt will b e 
gi ve n a n d 3 D gra die nt-ec h o seri es will b e ta ke n a n d will b e re peate d 4 0 
sec o n ds t hereaft er, f oll o wi n g I V a d mi nistrati o n of G d c o ntrast a g e nt at a d ose 
of 0. 1 m m ol/ k g per b o d y wei g ht. S u bse q ue ntl y, t he re m ai ni n g series will be 
ta ke n acc or di n g t o pr ot o c ol. 

S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
5 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
Electr ol yte ass ess me nt:  A bl o o d ( baseli ne) s a m ple f or electr ol yte a n al ysis 
will be c ollect e d j ust pri or t o t he H V starti n g t o dri n k L u me nti n ®  4 4.  A 
sec o n d bl o o d s a m ples will be c ollect e d o ne h o ur after t he bas eli ne bl o o d 
sa m ple. N o m ore L u me nti n ®  4 4 ca n be dr u n k after t his bl o o d sa m pl e has 
bee n c olle cte d. A d diti o n al bl o o d sa m ples will be c ollecte d at 2, 4, 6, 8, a n d 
2 4 h o urs p ost baseli ne sa m ples.  
S afet y ass ess m e nt:  T h e occ urre nce of a d v erse e v e nts a n d c o nc o mita nt 
treat me nt will be re c or de d f or t he d urati o n of t h e tri al.  
F or safet y reas o ns, s u bj ects will b e c o ntacte d wit hi n 2 t o 4 da ys after t he 
M R E e xa mi nati o n b y t he i n vesti gat or a n d as k e d a b o ut occ urre nce of a n y 
a d verse e ve nt. N o ot h er f oll o w- u p is pla n ne d. 
Tri al 
p o p ul ati o n 
H Vs f ulfilli n g t h e eli gi bilit y (i n-/e xcl usi o n) criteria.  
N u m ber of 
s u bjects 
A t otal of te n f ull y e val u a ble H Vs will be i n cl u de d i n t he trial. 
I n cl usi o n 
criteri a 
1.  Healt h y v ol u nteers of eit her ge n der at least 1 8 y ears at t h e ti me of si g ni n g 
t he i nf or me d c o nse nt.  
2.  Fe males m ust eit her pres e nt a n e gati v e pre g n a nc y test or be s ur gicall y 
steril e ( h ysterect o m y or t u bal li gati o n) or p ost me n o pa usal (i.e., 
e x perie n ce d 1 2 c o ns ec uti ve m o nt hs wit h o ut me nstr uati o n). 
3.  F oll o wi n g ver bal a n d writte n i nf or mati o n a b o ut t he trial, t h e s u bject m ust 
pr o vi d e si g ne d a n d dat e d i nf or me d c o nse nt bef ore a n y trial relat e d 
acti vit y is carrie d o ut. 
E xcl usi o n 
criteri a 
1.  Gl o mer ul ar Filtrati o n rate ( G F R) b el o w 6 0 ml/ mi n/ 1. 7 3 s q m b o d y 
s urface. All s u bjects will ha ve a plas ma creati ni ne ta ke n at scr ee ni n g f or 
cal c ulati o n of esti mate d G F R (e G F R). 
2.  Hist or y of dr u g relate d re acti o n t o ga d oli ni u m c o ntrast a ge nts. 
3.  Ha ve ha d g a d oli ni u m i njecti o n d uri n g t he last 4 w ee ks. 
4.  Cla ustr o p h o bi a n ot c o pi n g wit h M R E e xa mi nati o n. 
5.  Metal o bjects a n d me dical de vi ces i n t h e b o d y n ot j u d g e d b y t he 
i n vesti gat or t o be c o m pati ble wit h M R E. 
6.  H y perse nsiti vit y t o B us c o pa n ®  ( B ut yl h y osc o pi n). 
7.  Ha vi n g s wall o wi n g diffic ulties. 
8.  K n o w n all er g y t o e g g al b u me n.  

S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
6 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
9.  K n o w n se nsiti vit y t o a n y of t he c o m p o ne nts of t h e i n vesti gati o nal 
pr o d uct. 
1 0.  Cli nical s us pici o n of o n g oi n g disease b y t he i n vesti gat or.  
1 1.  Bei n g, i n t he o pi ni o n of t he i n vesti gat or, u nli kel y t o c o m pl y wit h t he 
cli nical trial pr ot oc ol. 
1 2.  Pre vi o usl y i ncl u d e d i n t his trial. 
1 3.  Partici pati n g i n or h a vi n g p artici p ate d i n a n ot h er cli ni cal trial wit hi n t he 
last 4 w ee ks.  
St atistic al 
a n al yses 
All s u bjects w h o ha ve c o m plete d t he trial will b e i ncl u de d i n t he st atistical 
e val uati o n.  
N o statistical tests will be c o n d ucte d. C o nfi d e nce i nter vals ma y be 
c o nstr ucte d a n d will t he n be 2-si d e d a n d of 9 5 % c o nfi de nce.  
C o nti n u o us d at a will b e s u m marise d usi n g descri pti ve st atistics ( N, m ea n, 
me di a n, sta n d ar d d e viati o n, mi ni m u m a n d ma xi m u m). Cate g orical dat a will 
be s u m marise d b y fre q u e nc y t a bles ( n u m b ers a n d perce nta ges).  
U nless ot her wise state d, all a nal yses will be d o ne o n o bser ve d cases wit h o ut 
a n y s u bstit uti o n of missi n g val ues. 
 

S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
7 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
S c he d ule of Assess me nts  
Visit/ C o nt act 
1 
2 
3 
4 
5 
P re-scree ni n g  
S cree ni n g 
M R E e x a mi n ati o n 
Bl o o d 
s a m pli n g 
F- U  (1 ) a n d e arl y 
ter mi n ati o n 
D a y 
- 2 1 t o - 1 
0 
1 4 
1 5 
Visit 2 + 2 d a ys 
Visit wi n d o w ( d a ys) 
 
 
+/- 7 d a ys 
- 
+ 2 
S u bject i nf or mati o n 
X 
X 
 
 
 
I n/e x cl usi o n criteria 
( X)( 2) 
X 
 
 
 
I nf or me d c o ns e nt 
 
X 
 
 
 
P h ysical e xa mi n ati o n 
 
X 
 
 
 
Pre g na nc y test  ( 3) 
 
X 
 
 
 
Creati ni ne bl o o d s a m ple 
 
X 
 
 
 
S u bject de m o gra p hics  
(i ncl. hei g ht a n d wei g ht) 
 
X 
 
 
 
C o n c o mit a nt treat me nt 
X 
X 
X 
X 
X 
C o n c o mit a nt ill nesses 
X 
X 
 
 
 
Me di cal hist or y 
X 
X 
 
 
 
A d verse e ve nt(s) rec or di n g 
 
 
X  ( 4) 
X 
X 
Place me nt of I V a ntec u bital 
ca n n ula  
 
 
X  ( 5) 
 
 

S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
8 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
Visit/ C o nt act 
1 
2 
3 
4 
5 
P re-scree ni n g  
S cree ni n g 
M R E e x a mi n ati o n 
Bl o o d 
s a m pli n g 
F- U  (1 ) a n d e arl y 
ter mi n ati o n 
D a y 
- 2 1 t o - 1 
0 
1 4 
1 5 
Visit 2 + 2 d a ys 
Visit wi n d o w ( d a ys) 
 
 
+/- 7 d a ys 
- 
+ 2 
M R E Sca n 
 
 
X 
 
 
Dis pe nsi n g of L u me nti n ®  4 4  
 
 
X 
 
 
A d mi nistrati o n of G d c o ntrast 
( 6) 
 
 
X 
 
 
A d mi nistrati o n of B usc o pa n ® ( 6)  
 
 
X 
 
 
E val u ati o n of e xte nsi o n a n d 
diste nsi o n of b o wel filli n g 
a ge nts 
 
 
X 
 
 
Bl o o d sa m pli n g 
 
 
X  (5 ) 
( pre-, 1, 2, 4, 6, 8 h)  
X 
( 2 4 h) 
 
C o m plia nce 
 
 
X 
 
 
1)  S u bjects will b e c o ntacte d b y tele p h o n e t w o t o f o ur w or ki n g d a ys p ost M R E assess m e nt. 
2)  O nl y s o m e of t he criteria will b e c h ec k e d i n cl u di n g, i ncl usi o n crit eri o n 1 a n d e x cl usi o n criteri a 2, 3, 4, 5, 6, 7, 8, 1 2 a n d 1 3. 
3)  Uri n e pre g na nc y test of all fe males w h o are n ot s ur gicall y sterile ( h ysterect o m y or t u bal li g ati o n) or p ost m e n o pa usal (i.e., e x p erie n ce d 1 2 c o nsec uti v e 
m o nt hs wit h o ut me nstr uati o n). 
4)  T ele p h o n e i nter vie ws will b e c o n d u cte d 2 da ys after M R E ass ess m e nt t o i n v esti g ate if a n y A Es occ urr e d d uri n g t h e first da ys after t h e i ma gi n g pr oce d ure  
5)  A n I V a ntec u bit al ca n n ula will b e place d f or pre- bl o o d sa m pl es a n d use d d uri n g t h e first 8 h i n cl u di n g a d mi nistrati o n of ga d oli ni u m d uri n g t he M R E 
pr o ce d ure. T h ereaft er it will be discar de d. Bl o o d sa m pli n g o n t h e f oll o wi n g d a y ( 2 4 h ti me p oi nt) will be dra w n wit h o ut a ca n n ula. 
6)  Ga d oli ni u m ( G d) a n d B usc o pa n ® will o nl y b e a d mi nistere d as p art of t h e M R E e xa mi n ati o n. 
 
 

S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
9 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
2  
L I S T O F T R I A L P E R S O N N E L 
S p o ns or 
L u me nt A B 
S c heele vä g e n 2 2 
B o x 7 1 9 
S E- 2 2 0 0 7 L u n d 
S we de n 
P h o n e: + 4 6 7 0 8 7 6 1 0 6 5 
E- Mail: ol of. b o o k @l u me nta b.c o m  
 
Cli nical Pr oject Ma na ger  
J o ha n Q ue nsel, C E O 
P h o n e: + 4 6 7 6 0 4 6 9 7 4 4 
E- Mail: j q @ qcrc.se  
 
Res p o nsi ble M e dical Officer 
R d. Ja n Marsal, M D, P h D 
De part me nt of Gastr oe nt er ol o g y 
S ka ne U ni v ersit y H os pital 
S U S L u n d E A 1 2 
S E- 2 2 1 8 5 L u n d 
S we de n 
P h o n e: + 4 6 4 6 1 7 7 0 0 3 
M o bil e p h o ne: + 4 6 7 0 9 8 2 2 0 0 8 
E- mail: j a n. marsal @ me d.l u.se 
Pri nci pal i n vesti gat or  
Dr. Peter Lea n der, M D, P h D 
R ö nt ge n, Perit us kli ni ke n A B 
S c heele vä g e n 8 
S E- 2 2 3 6 3 L u n d 
S we de n 
P h o n e: + 4 6 4 6 2 8 8 6 0 3 0 
M o bil e p h o ne: + 4 6 7 6 8 8 7 1 0 6 9 
E- Mail: p eter.lea n der @ p erit us kli ni ke n.se 
 
 
 

S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
1 0 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
3  
T A B L E O F C O N T E N T S 
1  
Pr ot oc ol S y n o psis ...................................................................................................... 2  
Sc h e d ul e of Ass ess m e nts ............................................................................................................................ 7  
2  
List of Tri al Pers o n n el .............................................................................................. 9  
3  
T a ble of c o nte nts ..................................................................................................... 1 0  
4  
List of A b b re vi ati o ns a n d Defi niti o ns of Ter ms ................................................... 1 4  
5  
I ntr o d u cti o n ............................................................................................................. 1 6 
5. 1  B ac k gr o u n d a n d st u d y r ati o n al e ..................................................................................................... 1 6  
5. 2  L u m e nti n ® 4 4 ................................................................................................................................... 1 6 
5. 3  Cli nic al d ev el o p m e nt t o d at e ........................................................................................................... 1 7  
5. 4  Ris k- B e n efit Ass ess m e nt .................................................................................................................. 1 8  
6  
Tri al O bjecti v es ....................................................................................................... 1 9  
6. 1  Pri m ary O bj ectiv e ............................................................................................................................ 1 9  
6. 2  S ec o n d ar y O bj ectiv es ...................................................................................................................... 1 9  
7  
O ver all D esi g n a n d Pl a n of t he Tri al..................................................................... 1 9  
7. 1  Tri al Ov ervi e w ................................................................................................................................. 1 9  
7. 2  O utc o m es ........................................................................................................................................ 2 0  
7. 2. 1  
Pri m ar y O utc o m e .................................................................................................................. 2 0  
7. 2. 2  
S ec o n d ar y O utc o m es ............................................................................................................. 2 0  
7. 3  J ustific ati o n of t h e Tri al D esi g n ....................................................................................................... 2 0 
7. 3. 1  
J ustific ati o n f or D esi g n a n d P ar a m et ers ................................................................................ 2 0 
7. 3. 2  
J ustific ati o n f or R o ut e a n d D os a g e ........................................................................................ 2 1 
8  
Tri al P o p ul ati o n ...................................................................................................... 2 3  
8. 1  I ncl usi o n Crit eri a ............................................................................................................................. 2 3 
8. 2  Excl usi o n Crit eri a ............................................................................................................................. 2 3  
8. 3  S u bj ect Wit h dr a w al a n d R e pl ac e m e nt ............................................................................................ 2 4  
8. 3. 1  
Wit h dr a w al fr o m Tri al T h er a p y ............................................................................................. 2 4  
8. 3. 2  
Wit h dr a w al fr o m St u d y ......................................................................................................... 2 4  
8. 4  D efi niti o n of E n d of St u d y ................................................................................................................ 2 5  

S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
1 1 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
8. 5  M e dic al C ar e of S u bj ects aft er E n d of St u d y ................................................................................... 2 5  
8. 6  Pl a n n e d S a m pl e Siz e a n d N u m b er of Tri al C e ntr es ......................................................................... 2 5  
9  
I n vesti g ati o n al P r o d uct a n d P r oce d u res ............................................................... 2 6 
9. 1  I n v esti g ati o n al pr o d uct ................................................................................................................... 2 6 
9. 2  D os a g e a n d A d mi nistr ati o n............................................................................................................. 2 7  
9. 3  P ac k a gi n g, L a b elli n g a n d St or a g e ................................................................................................... 2 7  
9. 4  Dr u g Acc o u nt a bility ......................................................................................................................... 2 7  
9. 5  L u m e nti n ® 4 4 Ex p os ur e a n d C o m pli a nc e ......................................................................................... 2 7 
1 0  Pr o hi bite d Pre vi o us a n d C o nc o mit a nt Me dic ati o n ............................................. 2 8  
1 0. 1  
C o nc o mit a nt M e dic ati o n ............................................................................................................ 2 8  
1 0. 2  
P er mitt e d/ Pr o hi bit e d M e dici n es ................................................................................................ 2 8  
1 0. 3  
P er mitt e d/ Pr o hi bit e d Pr oc e d ur es ............................................................................................... 2 8  
1 0. 4  
Pr ec a uti o ns/ o v er d os e ................................................................................................................. 2 9  
1 1  Visit sc he d ule a n d assess me nt descri pti o n ............................................................ 3 0  
1 1. 1  
Visit sc h e d ul e .............................................................................................................................. 3 0  
1 1. 1. 1  
Pr e-scr e e ni n g visit ( Visit 1: D a y - 2 1 t o - 1) ......................................................................... 3 0  
1 1. 1. 2  
Scr e e ni n g visit ( Visit 2: D a y 0) ........................................................................................... 3 0  
1 1. 1. 3  
M R E ex a mi n ati o n visit ( Visit 3: D a y 1 4) ............................................................................ 3 0  
1 1. 1. 4  
Bl o o d s a m pli n g visit ( Visit 4: D a y 1 5) ................................................................................ 3 1  
1 1. 1. 5  
F- U a n d e arl y t er mi n ati o n visit ( Visit 5: Visit 2 2 d a ys) ..................................................... 3 1  
1 1. 2  
Ass ess m e nt d escri pti o ns ............................................................................................................. 3 1  
1 1. 2. 1  
S u bj ect D e m o gr a p h y ........................................................................................................ 3 1  
1 1. 2. 2  
M e dic al Hist or y ................................................................................................................. 3 1  
1 1. 2. 3  
Pr e g n a nc y T est .................................................................................................................. 3 1  
1 1. 2. 4  
C o nc o mit a nt M e dic ati o n .................................................................................................. 3 2  
1 1. 2. 5  
Ass ess m e nt of S af et y ........................................................................................................ 3 2  
1 1. 2. 6  
El ectr olyt e ass ess m e nt ..................................................................................................... 3 2  
1 1. 2. 7  
M R E ex a mi n ati o n .............................................................................................................. 3 2  
1 1. 3  
O utc o m e ass ess m e nts ................................................................................................................ 3 3  
1 1. 3. 1  
Pri m ar y o utc o m es ............................................................................................................. 3 3  
1 1. 3. 2  
S ec o n d ar y o utc o m es ........................................................................................................ 3 4  
1 2  A d v ers e E v e nt S ....................................................................................................... 3 6  
1 2. 1. 1  
A d v ers e R e acti o n .............................................................................................................. 3 6  

S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
1 2 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
1 2. 1. 2  
U n ex p ect e d A d v ers e R e acti o n .......................................................................................... 3 6  
1 2. 1. 3  
S eri o us A dv ers e E v e nt ...................................................................................................... 3 6  
1 2. 2  
R e p orti n g of A d v ers e Ev e nts ....................................................................................................... 3 7  
1 2. 2. 1  
S ev erit y ............................................................................................................................. 3 7  
1 2. 2. 2  
C a us alit y ............................................................................................................................ 3 8  
1 2. 3  
F oll o w- u p of S u bj ects aft er A dv ers e E v e nts ................................................................................ 3 8  
1 2. 4  
A b n or m al L a b or at ory V al u es ...................................................................................................... 3 8  
1 2. 5  
R e p orti n g of S eri o us A d v ers e Ev e nts .......................................................................................... 3 8  
1 2. 6  
Pr ec a uti o ns/ Ov er d os e ................................................................................................................ 4 0  
1 3  St atistic al Met h o ds .................................................................................................. 4 1  
1 3. 1  
G e n er al st atistic al c o nsi d er ati o ns .............................................................................................. 4 1  
1 3. 2  
S a m pl e Siz e ................................................................................................................................. 4 1  
1 3. 3  
A n alys es S ets .............................................................................................................................. 4 1  
1 3. 4  
D escri pti o n of St atistic al A n alys es .............................................................................................. 4 1  
1 3. 5  
D at a c oll ecti o n ........................................................................................................................... 4 1  
1 4  E T HI C S ................................................................................................................... 4 2  
1 4. 1  
I n d e p e n d e nt Et hics C o m mitt e e (I E C) .......................................................................................... 4 2 
1 4. 2  
Et hic al C o n d uct of t h e Tri al ........................................................................................................ 4 2  
1 4. 3  
S u bj ect I nf or m ati o n a n d C o ns e nt ............................................................................................... 4 2  
1 4. 4  
S u bj ect D at a Pr ot ecti o n .............................................................................................................. 4 3  
1 4. 5  
Ot h er Et hic al a n d R e g ul at ory Iss u es ........................................................................................... 4 3  
1 4. 6  
Et hic al C o nsi d er ati o n st at e m e nt ................................................................................................ 4 3  
1 5  D at a M a n a ge me nt a n d Q u alit y Ass ur a nce ........................................................... 4 4  
1 5. 1  
Q u ality Ass ur a nc e ....................................................................................................................... 4 4  
1 5. 2  
Tri al M o nit ori n g ......................................................................................................................... 4 4  
1 5. 3  
C o nfi d e nti ality ............................................................................................................................ 4 5  
1 5. 4  
S o urc e D at a ................................................................................................................................ 4 6  
1 5. 5  
C as e R e p ort F or ms ( C R Fs) ........................................................................................................... 4 7  
1 5. 6  
D at a M a n a g e m e nt ..................................................................................................................... 4 7  
1 5. 7  
Arc hivi n g Tri al R ec or ds ............................................................................................................... 4 7  

S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
1 3 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
1 6  Tri al M a n a ge me nt .................................................................................................. 4 9  
1 6. 1  
Ti m e Sc h e d ul e ............................................................................................................................. 4 9  
1 6. 2  
Pr ot oc ol A m e n d m e nts ................................................................................................................ 4 9  
1 6. 3  
A gr e e m e nts ................................................................................................................................ 4 9  
1 6. 4  
D ur ati o n of t h e Tri al ................................................................................................................... 4 9  
1 6. 5  
C o m pl eti o n of Tri al ..................................................................................................................... 4 9  
1 6. 5. 1  
Tri al C o m pl eti o n Pr oc e d ur es ............................................................................................ 4 9  
1 6. 6  
Li a bility a n d I ns ur a nc e ................................................................................................................ 5 0  
1 6. 7  
Us e of i nf or m ati o n...................................................................................................................... 5 1  
1 6. 8  
P u blic ati o n P olic y ....................................................................................................................... 5 1  
1 7  Refe re nce List .......................................................................................................... 5 2  
1 8  A p p e n di ces ............................................................................................................... 5 3  
1 8. 1  
A p p e n dix 1: L u m e nti n 4 4 r ec o nstit uti o n pr ot oc ol s u m m ary ...................................................... 5 3  
1 9  SI G N A T U R E P A G E S ............................................................................................ 5 6  
 
 
 

S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
1 4 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
4  
L I S T O F A B B R E V I A T I O N S A N D D E F I N I T I O N S O F T E R M S 
A b d- C T  
A b d o mi nal C o m p uterise d t o m o gra p h y 
A D R  
A d verse Dr u g Reacti o n 
A E  
A d v ers e E v e nt 
A T C  
A nat o mical T hera pe utic C he mical 
A SI  
A d diti o nal Safet y I nf or mati o n  
b. w.  
B o d y wei g ht 
C D  
Cr o h n’s Disease 
CI  
C o nfi de nce I nt er v al 
C R F 
C T 
C ase Re p ort F or m 
C o m p uterise d T o m o gra p h y 
C T E  
C o m p uterise d T o m o gra p h y - e nt er o gra p h y 
C R O  
Cli nical Researc h Or ga ni zati o n 
D M F  
Dr u g Master File 
D R L  
Dr u g Refere n ce List 
E C  
E ur o pea n C o m m u nit y 
E E A  
E ur o pea n Ec o n o mic Area 
E M A  
E ur o pea n Me dici n es A ge nc y 
E U  
E ur o pea n U ni o n 
E W P  
E g g W hite Pr otei n (als o referre d t o as e g g al b u me n) 
F A  
F ull A nal ysis 
G C P  
G o o d Cli nical Practi ce 
G d  
G d G a d oli ni u m 
(e) G F R  
(esti m ate d) Gl o m er ul ar Filtrati o n Rate 
GI  
Gastr oi ntesti nal 
G R A S  
Ge nerall y Rec o g nize d as S afe 
H U  
H o u nsfiel d U nits 
H Vs  
Healt h y V ol u nteers 
I B  
I n v esti gat or Br oc h ure 
I C H  
I nter n ati o nal C o u ncil f or Har m o nisati o n of Tec h nical Re q uire me nts 
f or P h ar mace uticals f or H u ma n Use 
I E C  
I n d e pe n de nt Et hics C o m mitt ee 
I M P  
I n v esti gati o nal Me dici n al Pr o d u ct 
I P  
I n v esti gati o nal Pr o d uct 

S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
1 5 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
I V  
I ntr a v e n o us 
M R E  
Ma g neti c Res o n a nce - e nt er o gra p h y 
M RI  
Ma g neti c Res o n a nce I ma gi n g 
Me d D R A  
Me dical Dicti o n ar y f or R e g ulat or y Acti vities 
P h. E ur.  
E ur o pea n P h ar mac o pei a 
P o C  
Pr o of of C o nce pt 
R C D A S  
Ra di ol o gical Cr o h n’s disease A cti vit y S c ore 
R C E  
R el ati v e C o ntrast E n ha nce me nt 
R F  
R a di o Fre q ue nc y 
R OI  
R e gi o n of I nterest 
S A E  
Seri o us A d verse E v e nt 
S A P  
Statistical A n al ysis Pla n 
S T D  
Sta n dar d De viati o n 
S D V  
S o urce Data Verifi cati o n 
S U S A R  
S eri o us U ne x p ect e d S us pecte d A d verse R eacti o ns 
T E A E  
Treat me nt- E mer ge nt A d verse E ve nt 
T E A D R  
Treat m e nt- E mer ge nt A d verse Dr u g Reacti o n 
T M F  
Trial Master Fil e 
V/ V  
V ol u me p er v ol u me 
W/ W  
Wei g ht p er wei g ht 
W H O  
W orl d Healt h Or ga nisati o n 
 
 

S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
1 6 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
5  
I N T R O D U C T I O N 
5. 1  
B ac k gr o u n d a n d st u d y r ati o n ale 
L u me nti n ® 4 4 is bei n g de vel o p e d as a n o vel oral c o ntrast me di u m t o be use d i n 
dia g n ostic e xa mi nati o ns of t he a b d o me n. I nitial cli nical d e vel o p me nt has f oc use d 
c o m p uterize d t o m o gra p h y ( C T) ( Lea n der et al., 2 0 2 2; Lea n der et al., 2 0 2 2) w hile t he 
prese nt trial ai ms t o e x pl ore if t he si g n al c h aract eristics of L u me nti n ® 4 4 is fa v o ura bl e i n 
Ma g netic res o na nce e nt er o gra p h y ( M R E), a s p ecialize d t y pe of ma g n etic res o n a nce 
i ma gi n g ( M RI) p erf or me d wit h a c o ntrast materi al t o pr o d uce detail e d i m a ges of t he 
s mall i nt esti ne. 
Oral c o ntrast a g e nts are use d pri or t o a b d o mi nal C T (a b d- C T) a n d C T of t he s m all b o wel 
( C T-e nter o gra p h y, C T E) t o d e marcate b o wel l o o ps fr o m its s urr o u n di n gs a n d t o create a 
differe n ce i n d e nsit y bet w ee n t he b o w el a n d ot h er str uct ures i n t he a b d o m e n. Till n o w, 
t he o nl y c o ntrast a ge nts a v aila bl e a n d use d f or dia g n osis i n a b d- C T are p ositi ve, wit h 
H o u nsfiel d U nits ( H U) ar o u n d + 8 0, or ne utral, i.e., wit h H U ar o u n d a n d a b o ve zer o. B ot h 
a ge nt t y pes pr o vi de C T-i ma ges wit h u nsatisfact oril y l o w c o ntrast bet w ee n t he wall a n d 
l u me n of t h e s mall i nt esti ne. He nce, t h ere is a c o nsi d era ble nee d f or a b o wel filli n g 
c o ntrast a ge nt wit h tr ue n e gati ve H U t h at w o ul d offer n ota bl y lar ger l u me n-t o- wall 
c o ntrast, a prere q uisite f or i m pr o ve d m uc osal lesi o n det ect a bilit y.  
A p hase II st u d y ha v e be e n perf or m e d usi n g L u me nti n ® 4 4 as a c o ntrast a ge nt f or C T 
wit h e n c o ura gi n g res ults ( Lea n d er et al., 2 0 2 2). If t he s a me pr o d uct ca n als o b e use d i n 
M R E assess me nt it w o ul d be a n a d va nta ge f or a ra di ol o gi cal de part me nt t o o nl y ha n dle a 
si n gle oral s mall b o wel filli n g c o ntrast me di u m f or b ot h m o daliti es C T a n d M RI. I n 
a d diti o n, L u me nti n ® 4 4 has s h o w n t o ha v e a fa v o ura ble safet y pr ofile a n d ma y be a m ore 
t olera ble alter n ati v e t o t he oral me dia us e d t o da y i n b ot h C T a n d M RI. T his pr o of- of-
c o nce pt ( P o C) trial is perf or me d i n h ealt h y v ol u nt eers ( H Vs) wit h t h e ai m t o s h o w t hat 
L u me nti n ® 4 4 ca n b e us e d as a n oral, s mall b o wel filli n g c o ntrast a ge nt f or M R E.  
5. 2  
L u me nti n ®  4 4  
L u me nti n ®  4 4 is a n o vel, H U- n e gati v e c o ntrast a g e nt w hic h is f or m ulate d as a p o w der f or 
oral f oa m. T he p o w der pr o d uct c o ntai ns e g g w hit e pr otei n ( E W P) as f oa mi n g a ge nt, 
xa nt ha n g u m as sta biliser, p h os p h ate salts as b ufferi n g a ge nts, a n d fla v o uri n g.  
Pri or t o use, t he p o w der is mi xe d wit h water a n d w hi p p e d t o a sta ble f o a m, c o ntai ni n g 
4 4 % v/ v air a n d less t h a n 4 % w/ w dr y matter, w hic h is orall y a d mi nistere d. T he 
w hi p pe d, rea d y t o use L u me nti n ®  4 4 f oa m is sta ble wit h s uita ble c haract eristics (air 
c o nte nt, v ol u me, b u b ble size, h o m o g e neit y, c o nsiste nc y, sta bilit y a n d p alata bilit y) f or at 
least 2 h o urs.  

S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
1 7 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
T he air tra p p e d i n t he f oa m is t he ra di ol o gical ke y c o m p o ne nt t hat ca uses i m pr o ve d 
b o wel l u me n-t o- wall c o ntrast, wit h t he i nterface at t he s urface of t he m u c osal li ni n g of 
t he b o w el wall. T he e xter nal de marcati o n of t he s mall b o wel fr o m s urr o u n di n g or ga ns is 
o n par wit h sta n dar d filli n g a ge nts use d i n a b d- C T e xa mi nati o ns of t o da y, b ut mese nteric 
vessels b or deri n g t h e b o wel wall are ra di ol o gic all y better vis u alize d w h e n l o o ps are fille d 
wit h L u me nti n ®  4 4. T he reas o n f or t his is fe wer i ma ge artefa cts c o m p are d t o dil ut e d 
O m ni p a q ue ® ( O m ni p a q u e) i n t he gastr oi ntesti nal tract ( GI) tract. 
5. 3  
Cli nic al de vel o p me nt t o d ate 
A pre vi o us f or m ulati o n of t he a ge nt, L u me nti n ®  6 0 ( 6 0 % v/ v air), h as bee n teste d i n a 
pil ot I n vesti gat or i nitiate d trial, a p pr o ve d b y t h e l ocal et hics c o m mitt ee a n d l o cal i nstit ut e 
of ra diati o n pr ot ecti o n (ref 1). T he res ults were v ali date d b y 4 e xter nal re vie wers a n d 
s h o we d t h at L u me nti n®  6 0 i n its b o wel filli n g ca p acit y was o n par wit h c o nte m p oraril y 
use d b o wel filli n g a ge nts ( O m ni pa q ue a n d M o v pre p ® , M o v pre p). F urt her m ore, it was 
s u peri or i n c o ntrast bet w ee n b o wel l u me n a n d wall a n d re veale d a fa v o ura bl e pr ofile of 
si de effects wit h n o or o nl y mil d s y m pt o ms s u c h as b ur pi n g a n d f ull n ess wit h preser ve d 
b o wel c o nsiste nc y. T he pr o misi n g res ults o bt ai ne d wit h L u me nti n ®  6 0 e nc o ura ge d 
i m pr o ve d f or m ulati o n, lea di n g t o L u me nti n®  4 4, a n d c o nti n u e d cli nical de v el o p me nt t o 
f urt h er e x pl ore t he cli nical i m p orta nce of t he i m pr o v e d c o ntrast bet w ee n b o wel l u me n 
a n d b o wel wall wit h L u me nti n ®  4 4. A sec o n d g oal f or t he ne w f or m ulati o n was t o 
g uara ntee hi g h pati e nt acce pta nc e. 
L u me nti n ®  4 4 has b ee n i n vesti gate d i n t w o p hase II trials: 
I n t he c o m pl et e d a n d re p ort e d L U M- 0 0 1 tri al ( L ea n der et al., 2 0 2 2), t he relati ve mea n 
differe n ce i n c o ntrast de nsit y s h o w n o n a b d o mi nal C T-i m a ges w he n usi n g t h e c o ntrast 
a ge nt L u me nti n ®  4 4, was c o m pare d wit h a b d o mi n al C T-i ma ges usi n g dil ute d O m ni pa q u e 
a n d wit h a b d o mi nal C T-i ma ges usi n g M o v pre p i n s u bj ects referre d t o c o m p uterize d 
t o m o gra p hi c X-ra y e xa mi n ati o n of t he a b d o me n or t h orac o-a b d o mi nal C T-e xa mi nati o n.  
E val u ati o n of cli nical safet y data c o nfir m t he fa v o ura ble safet y pr ofile s h o w n wit h 
L u me nti n ®  4 4. T h e differe nce i n c o ntrast de nsit y bet wee n b o w el l u me n a n d b o wel wall 
was si g nifica ntl y lar ger aft er i nta ke of L u me nti n ®  4 4 as c o m pare d wit h t he c o m parat or 
c o ntrast a ge nts M o v pre p a n d O m ni pa q ue. T h ere w as n o statisti cal differe nce i n b o wel 
filli n g pr o perties. Neit h er was t here a n y differe nce i n di a g n ostic a bilit y bet wee n 
L u me nti n ®  4 4 a n d M o v pre p or O m ni pa q ue i n t his p atie nt p o p ulati o n ( w hic h ha d neit h er 
b o wel disease n or b o wel s y m pt o ms). T he s u bj ects’ assess me nts of taste, s mell, 
c o nsiste nc y, a bilit y t o s wall o w, a n d f ull ness place d L u me nti n ®  4 4 bet wee n O m ni p a q ue 
a n d M o v pre p. 

S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
1 8 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
I n trial L U M- 0 0 2, t he Ra di ol o gi cal Cr o h n’s disease Acti vit y Sc ore ( R C D A S) of a C T E 
perf or me d wit h L u me nti n ® 4 4 as a b o wel filli n g c o ntrast a ge nt w as c o m p are d wit h t he 
R C D A S of a r o uti nel y p erf or me d M R E i n patie nts wit h s m all b o wel Cr o h n’s disease. 
E val u ati o n of cli nical safet y data c o nfir ms t he fa v o ura ble safet y pr ofile s h o w n i n tri al 
L U M- 0 0 1. T his trial has bee n c o m plete d b ut efficac y e v al u ati o n is o n g oi n g. 
F urt her details are a vaila bl e i n t h e L u me nti n ® 4 4 I n v esti g at or Br oc h ur e (I B). 
5. 4  
Ris k- Be nefit Assess me nt   
E W P is wi del y use d as a f o o d i n gre die nt. All e xci pie nts i n L u me nti n ®  4 4, are of 
p har mac o p o eia q ualit y ( b uffer a n d st a biliser). T h e fla v o ur c o m plies wit h re g ulati o ns 
c o ncer ni n g fla v o uri n g i n f o o d a n d f o o d a d diti v es.  
T he si d e effects re p orte d b y s u bjects dri n ki n g u p t o 1. 2 L of t he L u me nti n ®  4 4 
f or m ulati o n i n pre vi o usl y c o n d uct e d trials i n dicate t hat L u m e nti n®  4 4 was well t olerate d 
wit h o nl y mil d t o m o d erate A Es re p ort e d.  
All er gic reacti o ns t o war ds e g g pr otei n ca n n ot b e e xcl u de d a n d pati e nts wit h a k n o w n 
se nsiti vit y t o war ds e g g s h o ul d n ot be e x p ose d t o L u me nti n ®  4 4.  
I n g esti o n of a lar g e v ol u me of f oa m i n a s h ort ti m e ma y ha ve a n i m p act o n t h e res or pti o n 
patter n of c o n c o mita nt me dicati o ns. I nta ke of ot her me dicati o ns, w hic h are a bs or be d i n 
t he s mall b o wel, a n d ha vi n g a narr o w t h era p e uti c wi n d o w, s h o ul d b e a v oi d e d wit hi n a 
peri o d of 4 h o urs bef ore a n d u ntil 1 h o ur after a d mi nistrati o n of L u me nti n ®  4 4. 
P ote ntial si d e effects ass oci at e d wit h i ntra ve n o us (I V) cat heterizati o n i ncl u d e i nserti o n 
site pai n, p hle bitis, he mat o ma f or mati o n a n d i nf us ate e xtra v asati o n. Mec h a ni cal iss u es 
s uc h cat heter o bstr ucti o n/ occl usi o n a n d disl o d ge me nt ma y occ ur. T he h os pital sites st aff 
is ver y fa miliar a n d al ert t o si g ns a n d s y m pt o ms of s uc h c o m plicati o ns, a n d pre ve nti v e 
meas ures are i n pl ace, as well as i nter v e nti o n pr o ce d ures f or if/ w h e n c o m plicati o ns d o 
occ ur. T h e I V cat heter will re mai n i n pl ace f or t h e d urati o n of t he visit 2 ( da y of M R E 
pr oce d ur e), u ntil c oll ecti o n of 8 h bl o o d sa m ple.  
T he pr o p ose d P hase II st u d y will e nr ol o nl y H Vs a n d as s uc h n o direct b e nefit is e x pect e d 
f or t he trial s u bjects. 
Ris ks ass oci ate d wit h C o vi d- 1 9  
C o nsi deri n g t hat t he s u bjects i n t h e trial will b e H Vs, t he ris k of c o ntracti n g C O VI D- 1 9, 
as part of t he trial pr oce d ures is c o nsi d ere d l o w.  
All s u bject visits t o t h e h os pital will occ ur i n faciliti es w hi c h are n ot use d f or patie nts 
wit h C O VI D- 1 9. Pr oce d ures t o pre ve nt C O VI D- 1 9 i nfecti o n, as rec o m m e n de d b y t he 
S we dis h “f ol k häls o m y n di g h ete n”, will b e f oll o we d.  
 

S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
1 9 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
6  
T R I A L O B J E C T I V E S 
6. 1  
Pri m a r y O bjecti ve 
T o e val u ate if L u m e nti n ®  4 4 use d as a s mall b o w el filli n g a ge nt i n M R E e xa mi nati o n 
ge nerat es i ma ges wit h acce pta bl e di a g n ostic q ualit y. 
6. 2  
S ec o n d ar y O bjecti ves 
 T o e val u ate plas ma electr ol yt es i n cl u di n g, p otassi u m, s o di u m, p h os p hate, a n d 
calci u m, as well as i o nize d cal ci u m c o n ce ntrati o n le vels d uri n g 2 4 h o urs after i nt a k e 
of L u m e nti n ®  4 4. 
 T o e val u ate b o w el filli n g pr o perties (e xte nsi o n a n d diste nsi o n) of L u me nti n ®  4 4. 
 T o e val u ate t h e s afet y a n d t ol era bilit y of L u me nti n ®  4 4 i nt a ke. 
7  
O V E R A L L D E S I G N A N D P L A N O F T H E T R I A L 
7. 1  
Tri al O ver vie w 
T his is a n u nc o ntr olle d, si n gle ce ntre p h ase II trial. E nr olle d H Vs ( n = 1 0) will u n der g o 
G d-e n ha n ce d M R E after oral i nt a k e of L u me nti n ® 4 4. 
I ntereste d H Vs will be i de ntifi e d pri maril y a m o n g m e dical st u de nts at t he me di cal 
h os pitals at Mal m ö a n d L u n d. P osters will be place d at t he d e p art me nts a n d i n vitati o n 
lett ers will be ha n de d o ut. 
T he H Vs i ntereste d i n partici p ati n g will be i n vite d t o atte n d a pre-scree ni n g visit w h ere 
t heir s uit a bilit y base d o n a ge a n d h ealt h stat us will b e assesse d. Fiftee n H Vs w h o f ulfil 
t he pre-scree ni n g criteria a n d are i ntereste d i n parti ci pati n g will be as k e d t o atte n d a 
scree ni n g visit at t he cli ni c a n d if eli gi ble f or t he trial t h e y will t he n visit t he cli nic f or t he 
M R E assess me nt wit hi n 1- 2 wee ks.   
O nl y t he i nitial 1 0 of t h e eli gi ble H Vs will be as ke d t o c o me f or t he M R E e xa mi nati o n 
a n d t he re mai ni n g eli gi bl e s u bjects will be as ke d t o sta n d b y i n case a n y of t he 1 0 
s u bj ects are u n a ble t o c o me or ca n n ot u n der g o t he e xa mi nati o n. 
H Vs will be as ke d t o fast f or 6 h o urs pri or t o t he e xa mi nati o n o n t he d a y of t h e M R E 
e xa mi nati o n. S m all a m o u nt of clear li q ui d is all o we d u p t o 2 decilitres. Pri or t o M R E, 
L u me nti n ®  4 4 will b e pr o vi de d t o t he m i n v ol u mes of u p t o 1, 5 0 0 m L a n d at least 1, 1 0 0 
m L of L u me nti n ® 4 4 m ust be dr u n k. T h e s u bj ects will b e as ke d t o dri n k t h e s ol uti o ns of 
oral c o ntrast a g e nt wit hi n 4 5 mi n utes t o 1 h o ur.  
S u bjects n ot a ble t o dri n k at least 1. 1 L of L u me nti n ® 4 4 will be wit h dra w n fr o m t he 
trial. 

S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
2 0 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
Pri or t o t he i nt a k e of L u me nti n ®  4 4, a n I V a ntec u bital ca n n ula will be place d a n d use d f or 
bl o o d sa m pli n g a n d a d mi nistrati o n of g a d oli ni u m ( G d) c o ntrast a ge nt d uri n g t he M R E 
assess me nt. 
7. 2  
O utc o mes 
7. 2. 1  Pri m ary O utc o me 
Vis u al e val uati o n of t he M R E i ma ges fr o m eac h trial s u bject wit h res pect t o m otilit y, 
artefacts, m uc osal e v al uati o n a n d o v erall di a g n ostic i m pressi o n. 
7. 2. 2  S ec o n d ary O ut c o mes 
 C o n ce ntrati o n of plas ma electr ol ytes i ncl u di n g, p otassi u m, s o di u m, p h os p hate, a n d 
calci u m, as well as i o nize d cal ci u m i n bl o o d sa m pl es ta ke n at T 0 h, T 1 h, T 2 h, T 4 h, 
T 6 h, T 8 h, a n d T 2 4 h. 
 B o wel filli n g pr o perties (e xte nsi o n a n d dist e nsi o n) i n eac h of 5 s electe d s u b-se g me nts 
of t h e s mall b o wel. 
 A n y treat me nt e mer ge nt a d verse e v e nts ( T E A Es) a n d treat me nt e m er ge nt a d verse 
dr u g reacti o ns ( T E A D Rs). 
7. 3  
J ustific ati o n of t he Tri al Desi g n 
7. 3. 1  J ustific ati o n f or Desi g n a n d P ar a meters 
L u me nti n ®  4 4 is c urre ntl y bei n g de vel o pe d t o be use d as a s mall b o wel filli n g c o ntrast 
a ge nt w he n C T e x a mi nati o n is perf or me d. T w o cli nical trials ha ve s o far bee n p erf or me d 
a n d a p h ase 3 trial is pla n n e d t o start 2 0 2 3.  
M ost ra di ol o g y de part me nts perf or m b ot h C T a n d M R E e xa mi nati o ns a n d it is 
a d va nta ge o us a n d c o n ve nie nt f or t he m t o b e a ble t o pr o vi de t h e sa me oral c o ntrast a ge nt 
f or b ot h pr oce d ures. L u m e nti n®  4 4 is f o o d base d wit h Ge nerall y Re c o g niz e d as Safe 
( G R A S) e xci pie nts a n d h as i n t he pre vi o us cli nical trial bee n acce pt e d a n d t olerate d w ell 
wit h o nl y mil d t o m o d erate A Es re p ort e d. I n t he L U M- 0 0 1 trial i n s u bjects referre d f or 
a b d o mi nal C T-e xa mi nati o n t hat e val u at e d t he C T i ma ge q u alit y a n d dia g n ostic feasi bilit y 
of L u m e nti n ® 4 4 i n c o m paris o n wit h dil ut e d O m ni p a q ue a n d M o v pr e p, t he m ost 
c o m m o n T E A Es i n t he L u me nti n ®  4 4 ar m, were flat ule nce ( 4 s u bj ects, 2 2 %) a n d na us ea 
( 2 s u bj ects, 1 1 %). I n t h e L U M- 0 0 2 cli nical trial i n pati e nts wit h s mall b o wel Cr o h n’s 
disease t hat e val uate d L u m e nti n ® 4 4 as c o ntrast a ge nt i n C T-e nter o gra p h y as c o m par e d 
t o M R E, t h e m ost c o m m o n ( occ urri n g i n ≥2 s u bjects) T E A Es, i n t he L u me nti n®  4 4 ar m, 
were diarr h oea ( 1 0 s u bjects, 1 8 %), na usea ( 3 s u bjects, 5 %), a n d flat ule nce ( 2 s u bj ects, 
4 %). 

S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
2 1 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
T o be a ble t o use L u me nti n ® 4 4 i n M R E, t he dia g n ostic q ualit y ca n n ot be i nferi or t o t he 
sta n dar d oral re gi me n. T heref ore, t he trial select e d pi v otal p ara meters i n rea di n g M R E as 
pri mar y e n d p oi nts.  
As t he air i n L u me nti n ma y de gra d e t h e i ma ge q u alit y i n M RI i n t he i nterface t o s oft 
tiss ue t he m ost rel e va nt p ara met ers were c h os e n. I n m otilit y se q ue nces t h e m o vi n g s mall 
i ntesti ne fille d wit h air ma y a g gra v at e t h e pr o ble m a n d t he ot her para meters w here t he 
s mall i nt esti ne s h o ul d re mai n still it is m ost rele va nt t o scr uti nize t he str uct ures, e. g., 
m u c osal f ol ds, i n t h e i nterface b et w ee n air a n d s oft tiss u es. 
It is i m p orta nt f or t he q u alit y of t he M R E i ma ges t h at t he s m all b o wel is a de q uatel y fille d 
wit h t h e c o ntrast a g e nt. T h e cli nical e n d p oi nt meas uri n g filli n g pr o perties is t heref ore 
i ncl u de d. E xte nsi o n is t he meas ure me nt of h o w far d o w n i n t h e s mall b o wel t he c o ntrast 
a ge nt has reac h e d, a n d t he diste nsi o n p ara meter meas ures t he h o w diste n de d ( wi d e ne d) 
t he s mall b o wel is.  
P alata bilit y of t he c o ntrast a ge nt is a n i m p orta nt fact or f or t he s u bject’s acce pt a nce a n d 
a bilit y t o dri n k it. T he s u bjects are t h eref or as k e d t o e val uate feat ures d escri bi n g h o w 
t he y e x p erie n ce dri n ki n g t he L u me nti n®  4 4 f oa m. 
T he c h oi ce of n ot i n cl u di n g a c o m p arat or a n d e x p ose t he H V t o a n ot h er c o ntrast a ge nt 
ha ve b ee n ma de b ase d o n t h at t he ai m of t h e tri al is t o i n vesti gate t he ge neral q ualit y of 
t he M R i ma ges w h e n usi n g L u me nti n®  4 4, a n d t hat b ot h t h e i n v esti g ati o nal M R E 
e xa mi nati o n a n d t h e dr u g L u me nti n ®  4 4 are safe t o use. Fr o m a m e dical, e m pirical, 
pers pecti ve it is n ot c o nsi d ere d necessar y t o i ncl u d e m ore t h a n 1 0 s u bjects t o ge nerate 
data s ufficie nt f or s h o wi n g P o C. T h e sa m pl e size is n ot deter mi n e d o n a n y mat he mati cal 
gr o u n ds as t his is a P o C trial.  
H Vs t o be e nr olle d i n t he trial m ust be a ble t o u n der g o a n M R E e x a mi nati o n a n d s h o ul d 
n ot h a ve a n y k n o w n e g g all er g y. 
7. 3. 2  J ustific ati o n f or R o ute a n d D os a g e  
A t ot al of 7 3 s u bjects i n pre vi o us cli nical trials ( L U M- 0 0 1 a n d L U M- 0 0 2) were as ke d t o 
dri n k bet w ee n 0. 7 5 - 1. 5 L f oa m a n d t h e a vera ge a m o u nt dr u n k was 1 0 2 6 m L of 
L u me nti n ®  4 4 f oa m. T he a m o u nt of c o ntrast a g e nt t hat a s u bj ect ca n dri n k varies b et w ee n 
s u bj ects de pe n di n g o n e. g., a ge, w ei g ht, ge n d er a n d me dical c o n diti o n. It is t h eref ore 
necessar y t o d efi n e t h e rec o m me n de d d ose wit hi n a ra n ge.  
T his trial will recr uit pre d o mi na ntl y y o u n g H Vs, a n d electr ol yte le vels will be 
i n v esti g at e d. T he ra n ge is t h eref or e narr o wer a n d t h e l o wer li mit i n t h e ra n ge is als o 
hi g her t ha n i n pre vi o us trials. T he l o wer li mit i n t h e d ose ra n g e is set t o 1. 1 L. T he 
rec o m me n de d d os e will b e 1. 2 L wit h t he all o we d u p per ra n ge set t o 1. 5 L.  

S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
2 2 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
T he r o ute of a d mi nistrati o n is acc or di n g t o sta n d ar d practice f or a n oral c o ntrast a ge nt. 
 
 

S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
2 3 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
8  
T R I A L P O P U L A T I O N 
T he trial p o p ulati o n will c o nsist of healt h y v ol u nteers. 
T he s u bjects m ust be a bl e t o pr o vi de writte n i nf or me d c o ns e nt a n d me et all t h e i ncl usi o n 
criteria a n d n o ne of t he e xcl usi o n criteria. 
8. 1  
I ncl usi o n Criteri a 
S u bjects will be e ntere d i nt o t his trial o nl y if t h e y meet all t he f oll o wi n g criteria: 
1.  Healt h y v ol u nteers of eit her ge n der at least 1 8 years at t he ti me of si g ni n g t he 
i nf or me d c o nse nt.  
2.  Fe males m ust eit h er prese nt a ne gati v e pre g na nc y test or be s ur gicall y steril e 
( h yst erect o m y or t u b al li gati o n) or p ost me n o p a us al (i.e., e x peri e nce d 1 2 c o nsec uti v e 
m o nt hs wit h o ut me nstr uati o n). 
3.  F oll o wi n g ver bal a n d writte n i nf or mati o n a b o ut t he trial, t he s u bj ect m ust pr o vi d e 
si g n e d a n d date d i nf or m e d c o nse nt b ef ore a n y tri al relate d a cti vit y is carrie d o ut. 
8. 2  
E xcl usi o n Criteri a 
S u bjects will n ot be e nr olle d if t he y m eet a n y of t h e f oll o wi n g crit eria: 
1.  G F R bel o w 6 0 ml/ mi n/ 1. 7 3 s q m b o d y s urface. All s u bjects will ha ve a plas ma 
creati ni n e ta k e n at scree ni n g f or calc ul ati o n of e G F R. 
2.  Hist or y of dr u g relate d reacti o n t o g a d oli ni u m c o ntrast a ge nts. 
3.  Ha ve ha d g a d oli ni u m i nj ecti o n d uri n g t he last 4 w ee ks. 
4.  Cla ustr o p h o bia n ot c o pi n g wit h M R E e xa mi nati o n. 
5.  Metal o bj ects a n d me dical de vi ces i n t h e b o d y n ot j u d ge d b y t h e i n vesti gat or t o be 
c o m p ati ble wit h M R E. 
6.  H y perse nsiti vit y t o B usc o pa n ®  ( B ut yl h y osc o pi n). 
7.  Ha vi n g s w all o wi n g diffic ulties. 
8.  K n o w n aller g y t o e g g al b u me n.  
9.  K n o w n se nsiti vit y t o a n y of t he c o m p o ne nts of t he i n v esti g ati o n al pr o d uct. 
1 0.  Cli ni cal s us pici o n of o n g oi n g disease b y t he i n vesti gat or.  
1 1.  Bei n g, i n t he o pi ni o n of t h e i n v esti g at or, u nli k el y t o c o m pl y wit h t he cli nical trial 
pr ot oc ol. 
1 2.  Pre vi o usl y ra n d o mize d t o p artici pate i n t his trial. 
1 3.  P artici pati n g i n or ha vi n g partici p ate d i n a n ot her cli nical tri al wit hi n t he last 4 wee ks.  

S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
2 4 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
8. 3  
S u bject Wit h d r a w al a n d Re pl a ce me nt 
8. 3. 1  Wit h dr a w al fr o m Tri al T her a py 
S u bjects m ust be wit h dra w n if t he i nta ke of t he c o ntrast a ge nt has t o be st o p pe d, pl ease 
see secti o n 9. 2 D osa ge a n d A d mi nistrati o n. 
8. 3. 2  Wit h dr a w al fr o m St u dy 
S u bjects ma y wit h dra w fr o m t he trial at a n y ti m e a n d f or a n y reas o n wit h o ut prej u dice t o 
his or her f ut ure me dical care. 
S u bjects m ust be wit h dra w n u n der t he f oll o wi n g circ u msta nces: 
 T he s u bject wit h dra ws c o nse nt 
 S u bj ects w h o ha ve n ot faste d (clear water all o we d) f or at le ast si x h o urs pri or t o 
t he i nta ke of t he c o ntrast a ge nt  
 T he s u bject is u na ble t o dri n k at least 1. 1 L of L u me nti n ®  4 4 
 T he s u bject is u na ble t o c o m plete t h e M R E e xa mi n ati o n, d ue t o e. g., 
cl a ustr o p h o bia.  
 Vi ol ati o n of eli gi bilit y criteria 
S u bjects wit h dra w n d ue t o t h e a b o ve circ u msta nces will be re place d b y o n e of t h e fi v e 
re mai ni n g eli gi bl e H V s u bjects o n sta n d b y after scree ni n g.  
S u bjects ma y be re q uir e d t o wit h dra w after disc ussi o n wit h t h e S p o ns or a n d/ or 
I n v esti gat or f or t h e f oll o wi n g reas o ns: 
 A Es 
 Use of pr o hi bite d me dicati o n (see Secti o n 1 0 ) 
 At t h e discreti o n of t h e I n vesti g at or 
I n all cases, t h e reas o n(s) f or wit h dra wal m ust be rec or de d o n t h e Case Re p ort F or m 
( C R F). If a s u bject is pre mat urel y wit h dra w n fr o m t he trial f or a n y reas o n, t he 
I n v esti gat or m ust ma ke e ver y eff ort t o p erf or m t h e e val uati o ns descri b e d f or t h e Earl y 
Ter mi nati o n Visit (see S ecti o n Fel! Hitt ar i nte refere ns k äll a. ). 
If a s u bject has wit h dra w n i nf or me d c o nse nt a n d still a grees t o atte n d t he E arl y 
Ter mi nati o n Visit, t his will be d oc u me nt e d o n t h e C R F. 
F or s u bjects w h o are wit h dra w n after t he y recei v e t h e trial dr u g, t h e Earl y Ter mi n ati o n 
pa ge will be c o m pl ete d i n t he C R F.  
H Vs wit h dra w n pri or or d uri n g t h e M R E e xa mi nati o n (i.e., n o e val ua ble M R E sca n has 
bee n ge nerate d) will be r e place d b y a ne w H V. H Vs wit h dra w n after t he c o m pleti o n of 
M R E e xa mi n ati o n a n d N O T f ulfilli n g t he ma n dat or y criteria f or wit h dra w al liste d a b o ve 
will n ot be re place d.  

S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
2 5 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
8. 4  
Defi niti o n of E n d of St u d y 
T he e n d of trial visit will be t h e last s u bject last visit w hic h will occ ur at t he f oll o w u p 
visit, t w o da ys after t he M R E e xa mi n ati o n, or i n case of a n o n g oi n g A E at t he f oll o w u p 
visit, a n y a d diti o n al visit re q uire d f or A E f oll o w- u p. 
8. 5  
Me dic al C are of S u bjects after E n d of St u d y 
T he trial will o nl y i n cl u de healt h y v ol u nteers a n d t here is t heref ore n ot n ee d f or me dical 
care after t he trial. H o w e ver, i n cas e t he M R E e xa mi nati o n re veals a n y rele va nt 
pre vi o usl y u n k n o w n me dical c o n diti o n, t he s u bj ect will be i nf or me d a n d g ui de d t o 
c o ntact a p pr o pri at e me di cal e x p ertise. 
8. 6  
Pl a n ne d S a m pl e Si ze a n d N u m b er of Tri al Ce ntres 
It is pla n ne d t o e nr ol 1 0 e val ua ble s u bj ects i n a si n gle cli nical site.  
 
 

S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
2 6 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
9  
I N V E S T I G A T I O N A L P R O D U C T A N D P R O C E D U R E S 
9. 1  
I n vesti g ati o n al p r o d uct 
L u me nti n ®  4 4 P o w der f or oral f oa m (Ta ble 1 ) will b e ma n ufact ure d b y A p ote k 
Pr o d ucti o n & La b orat ori es A B, Pris ma vä ge n 2, S E- 1 4 1 7 5 K u n ge ns K ur v a, S we de n a n d 
pr o vi d e d i n la belle d w hit e sac hets c o ntai ni n g 1 7. 4 g p o w der. P ota bl e w ater 
(c o m merciall y a vail a ble still water 0. 5 L p er b ottle) f or t he pre p arati o n of t he f oa m will 
be use d.  
T a bl e 1: L u me nti n ® 4 4 P o w der f or o r al f o a m 
I n gre die nts 
C o nce ntr ati o n ( g/s ac het) 
E g g W hit e P o w der  
1 0. 0  
S o di u m di h y dr o ge n p h os p hate di h y drate 
( Na H2P O 4 • 2 H2O) 1 
1. 0 
Di p otassi u m p h os p hate ( K 2H P O 4) 1 
3. 4  
Xa nt ha n g u m 1 
2. 5  
Fl a v o ur 2 
0. 5  
1)  P h. E ur.: E ur o pea n P har mac o peia 
2)  T he fla v o ur c o m pli es wit h t he re g ulati o ns ( E C) 1 3 3 4/ 2 0 0 8 a n d ( E C) 1 7 8/ 2 0 0 2 
c o ncer ni n g fla v o uri n g i n f o o d a n d f o o d a d diti ves.  
 
L u me nti n ® 4 4 p o w der f or oral f oa m will b e d eli v ere d fr o m A P L t o t he cli ni cal site, b y 
or der via t h e h os pital p har mac y a n d st ore d te m p oraril y at t he sit e. T he i n vesti g ati o n al 
pr o d uct ( L u me nti n ® 4 4 f o a m) is t he n pre pare d i n-sit u b y a d di n g 0. 5 L p ota bl e water t o 
L u me nti n ® 4 4 p o w der c o ntai n e d i n o ne sac h et, a n d t he ble n d is t he n mi x e d t o a sta ble 
f oa m i n a d e dic at e d pre p arati o n u nit. T he fres hl y pre pare d f oa m will be a d mi nistere d t o 
t he patie nt wit hi n 5 t o 1 0 mi n utes as direct e d i n t h e cli nical trial pr ot oc ol. T he i n-
sit u pre parati o n will f oll o w a pr oce d ure attac h e d t o t h e cli nical trial pr ot o c ol. T he st aff 
res p o nsi ble f or t he i n-sit u pre parati o n will b e trai ne d usi n g t he pr oce d ure a n d t heir 
trai ni n g d oc u me nt e d i n t he Trial M ast er File ( T M F). T w o s ac hets ( 0. 9 L f o a m per sa c het) 
will be re q uire d p er s u bject.  
F or a detaile d des cri pti o n of t he pre p arati o n of L u me nti n ®  4 4 F o a m (see A p p e n di x 1 
L u me nti n ®  4 4 : L u m e nti n 4 4 rec o nstit uti o n pr ot oc ol s u m mar y ). 
L u me nti n ®  4 4 F o a m c o ntai ns t h e sa me i n gre die nts as L u me nti n®  4 4 P o w der f or oral 
f oa m, see F el! Hitt ar i nte refere ns k äll a. , e xce pt f or water a d de d d uri n g t h e pre parati o n. 

S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
2 7 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
9. 2  
D os a g e a n d A d mi nistr ati o n 
T he I n vesti g ati o nal pr o d ucts will b e ta ke n orall y b y t he s u bject d uri n g a p eri o d of 3 0 
mi n utes - 1 h o ur.  
A v ol u me of 1. 1 L t o 1. 5 L s hall be c o ns u me d. A stea d y i nt a ke rate of t he c o ntrast a ge nt 
is rec o m me n d e d t o g uara ntee f ull ness of t h e g astr oi ntesti n al tract fr o m st o mac h t o 
ter mi n al ile u m of t h e s mall b o wel.  
T he i nta ke of t he c o ntrast a ge nt will be st o p pe d i n case of a n A E occ urs or if t h e s u bject 
is u na bl e t o c o ns u me m ore t h a n 1. 1 L wit hi n 1 a n d ½ h o ur. T he s u bject will be 
wit h dra w n i n cas e t h e i nta ke of t he c o ntrast a ge nt has t o be st o p pe d.  
T he s u bject will b e wit h dra w n fr o m t h e trial if t h e ma xi m u m v ol u me of t he 
I n v esti gati o nal pr o d uct ta ke n b y t h e s u bj ect is l ess t h a n 1. 1 L.  
T here is n o ris k of o v er d ose. 
9. 3  
P ac k a gi n g, L a belli n g a n d St o r a ge 
L u me nti n ® 4 4 p o w der f or oral f oa m will b e s u p pli e d i n w hite sac hets la b elle d acc or di n g 
t o E U- G M P, A n ne x 1 3. Te n sac hets will be pl ace d i n a sec o n dar y pac k a ge c o nsisti n g of 
w hite u n pri nte d car d b oar d. L u me nti n ® 4 4 p o w der f or oral f o a m s h o ul d b e st ore d at r o o m 
te m perat ure ( bel o w 2 5° C) i n a restrict e d area, accessi ble t o a ut h orise d pers o n nel o nl y.  
9. 4  
Dr u g A cc o u nt a bilit y 
T he I n vesti g at or is res p o nsi ble f or mai nt ai ni n g acc urate i n vesti gati o n al pr o d uct 
acc o u nta bilit y rec or ds t hr o u g h o ut t he trial. 
Eac h dis p e nsi n g of i n vesti g ati o nal pr o d uct will b e d oc u me nte d i n t he dr u g acc o u nta bilit y 
l o g a n d t he C R F.  
All u n use d i n vesti gati o nal pr o d uct ( L u me nti n ®  4 4 p o w der f or oral f oa m) will be ret ur ne d 
t o L u me nt A B at t he e n d of t h e trial.  
9. 5  
L u me nti n ®  4 4 E x p os ure a n d C o m pli a n ce 
All L u me nti n ®  4 4 c o nt ai ners will be wei g he d b ef ore t he y are dis p e nse d t o t he s u bject a n d 
a gai n w he n ret ur ne d b y t he s u bject a n d t hese w ei g hts (i n gra m) will be rec or de d i n t he 
C R F. 
T he e xact v ol u me of t he L u me nti n ®  4 4 f oa m i n t h e dri n ki n g c o nt ai ner will be deter mi n e d 
pri or t o dis pe nsi n g it t o t he s u bjects b ut it will b e at least 1. 1 L. T he w ei g ht of t he 
c o ntrast a ge nt will be meas ure d pri or t o dis p e nsi n g a n d a n y re mai ni n g c o ntrast a ge nt will 
be wei g he d after i nta ke. V ol u mes will be n ote d i n t he C R F Dr u g acc o u nta bilit y will be 
carri e d o ut at re g ular i nter v als, as s pecifi e d i n t he m o nit ori n g pla n. 

S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
2 8 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
Dr u g e x p os ure will be esti mate d base d o n t he wei g ht of i n gest e d c o ntrast a ge nt a n d t he 
wei g ht of t he s u bject.  
Data fr o m t his trial will be use d t o t he e xt e nt p ossi ble f or pr o vi di n g f ut ure a d vice as of 
h o w m uc h L u me nti n ®  4 4 s h o ul d be use d t o o btai n M R E sca ns wit h g o o d dia g n ostic 
rea da bilit y. 
1 0  P R O H I B I T E D P R E V I O U S A N D C O N C O M I T A N T M E D I C A T I O N 
1 0. 1  C o nc o mit a nt Me dic ati o n 
A n y me dicati o n t he s u bject ta kes ot her t h a n t h e i n vesti gati o nal pr o d u ct ( prescri b e d a n d 
o ver-t he-c o u nter- dr u gs) is c o nsi dere d a c o n c o mita nt me dicati o n. All c o nc o mita nt 
me di cati o ns m ust be rec or de d i n t he C R F. T he f oll o wi n g i nf or mati o n m ust be rec or de d i n 
t he C R F f or eac h c o nc o mita nt me dicati o n: g e neric n a me, r o ute of a d mi nistrati o n, start 
date, st o p date, d osa ge, a n d i n dicati o n. A n y c ha n g es i n t h e d osa ge or re gi m e n of a 
c o nc o mita nt treat m e nt m ust be rec or d e d i n t he C R F. 
At visit 1, s u bjects will be as ke d w h at me di cati o ns t he y ha ve ta ke n d uri n g t he l ast 2 
wee ks bef ore visit 1. C o n c o mita nt m e dicati o ns will be rec or de d at eac h visit a n d d uri n g 
tele p h o ne i nter vie ws, if a p plica ble.  
All s u bjects will recei ve: 
1.  A n i ntra v e n o us i njecti o n of B us c o pa n 4 0 m g. T he d ose gi ve n a n d b atc h n u m ber 
of B usc o pa n 4 0 m g will be n ote d i n t he C R F 
2.  A n i ntra v e n o us i njecti o n of t he G d c o ntrast a ge nt ( Clarisca n ®, 0. 5 M) d uri n g t he 
M R E-e xa mi nati o n at a d ose of 0. 1 m m ol/ k g b. w. T h e v ol u me gi ve n is t y picall y 
1 0 – 2 0 ml. T he d ose gi ve n a n d batc h n u m b er of t h e Clarisca n ®  0. 5 M will be 
n ote d i n t he C R F.  
1 0. 2  Per mitte d/ Pr o hi bite d Me dici nes 
All use of me di cati o n t a k e n b y a n y r o ute will be pr o hi bite d d uri n g 4 h o urs bef ore t a ki n g 
t he c o ntrast a ge nts a n d o ne h o ur p ost t he i nta ke. T hereafter o nl y c o ntrace pti v es a n d 
occasi o nal p ai n killers are all o we d.   
1 0. 3  Per mitte d/ Pr o hi bite d Pr oce d ures 
H Vs s h all n ot u n der g o m ore t ha n n or mal p h ysic al li vi n g d uri n g t he first 2 4 h of t he st u d y, 
mea ni n g t h at trai ni n g a n d har d p h ysical e x ercis e are n ot all o we d. 

S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
2 9 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
1 0. 4  Prec a uti o ns/ o ver d ose 
Ris ks ass o ciate d wit h i nt a ke of oral c o ntrast a ge nts i n cl u de d ys p ha gia wit h as pirati o n a n d 
sec o n d ar y p n e u m o nia. Alt h o u g h t his tri al i nte n ds t o e nr ol o nl y h ealt h y v ol u nteers a n d 
s u bj ects wit h ac ute pr o bl e ms are e xcl u de d, a pre-e mer ge nc y s mall b o w el st at us mi g ht be 
a g gra vat e d t o a n esta blis he d il e us b y i n g esti n g a lar ge v ol u me. Oral c o ntrast a ge nts 
s h o ul d n ot b e gi v e n t o s u bc o nsci o us s u bjects, t o t h ose wit h s wall o wi n g dis or ders, or a n 
ac ut e a b d o me n pr o bl e m.  
K n o w n se nsiti vit y or aller g y t o c o ntrast a ge nt i n gre die nts are e xcl usi o n crit eria i n cli ni cal 
st u dies. H o we ver, u n k n o w n se nsiti vities or aller gies mi g ht ca use reacti o ns t h at ma y nee d 
t o be me dicall y treat e d.  
I ntra ve n o usl y a d mi nist ere d G d m a y c a use aller gi c reacti o n of v ari o us se verit y fr o m a 
mil d r us h t o i nt e nsi v e care u nit treat me nt. T his is es peciall y tr ue f or t h ose wit h all er gi c 
reacti o ns t o a c o ntrast a g e nt earlier i n life. Aller gic reacti o n ma y be tri g ge d i n t h ose wit h 
ast h matic br o nc hitis a n d treate d wit h bet a- bl oc kers. R o uti nes f or ha n dli n g t hese cases are 
well k n o w n t o t h e staff w hic h is re g ul arl y trai n e d i n d eali n g wit h e mer ge n c y cases. 
E q ui p me nt f or e mer ge nc y care treat m e nt is a v aila ble at t he cli ni c a n d t he cli ni c is l ocate d 
i n cl ose pr o xi mit y t o t h e h os pit al e mer ge nc y car e de part me nt. Neit her B usc o p a n n or G d 
s h o ul d be a d mi nistere d t o p atie nts wit h se vere ki d ne y fail ure.  
 
 

S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
3 0 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
1 1  V I S I T S C H E D U L E A N D A S S E S S M E N T D E S C R I P T I O N 
1 1. 1  Visit sc he d ule  
1 1. 1. 1  Pre-scree ni n g visit ( Visit 1: D ay - 2 1 t o - 1) 
Pre-scree ni n g assess me nts will i ncl u de: 
 Rec or di n g of s u bject i nf or mati o n. 
 Rec or di n g of past m e dic al a n d s ur gical hist or y. 
 Rec or di n g of c o n c urre nt ill ness a n d treat me nts. 
 Eli gi bilit y c hec k wit h re gar ds t o i n cl usi o n criteri o n 1 a n d e xcl usi o n criteria 2, 3, 
4, 5, 6, 7, 8, 1 2 a n d 1 3. 
1 1. 1. 2  S cree ni n g visit ( Visit 2: D ay 0) 
S cree ni n g assess me nts will i ncl u de: 
 O btai ni n g of writte n i nf or me d c o nse nt pri or t o a n y st u d y s pecifi c pr oce d ure 
(i n cl u di n g scree ni n g pr oce d ures) b ei n g perf or me d. 
 Rec or di n g of s u bject i nf or mati o n a n d de m o gra p hi cs i n cl u di n g, date of birt h, se x, 
hei g ht a n d wei g ht 
 Rec or di n g of past m e dic al a n d s ur gical hist or y. 
 Rec or di n g of c o n c urre nt ill ness a n d treat me nts. 
 I n cl usi o n/ e xcl usi o n criteria. 
 Pref or mi n g a p h ysical e xa mi nati o n. 
 Fe males will be as ke d t o u n d erta ke a uri n e pre g na nc y test 
 O btai ni n g a creati ni ne bl o o d sa m pl e 
1 1. 1. 3  M R E e x a mi n ati o n visit ( Visit 3: D a y 1 4) 
D uri n g t his visit t h e M R E e xa mi n ati o n will b e perf or me d, i ncl u di n g t he f oll o wi n g 
assess me nts: 
 Rec or di n g of c o n c o mita nt treat me nts 
 Rec or di n g of A Es 
 Place me nt of t he I V a nt ec u bital ca n n ula 
 Dis p e nsi n g of L u me nti n ® 4 4 

S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
3 1 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
 M R E e xa mi n ati o n  
o  A d mi nistrati o n of G d c o ntrast 
o  A d mi nistrati o n of B usc o pa n ®  
 E val u ati o n of e xt e nsi o n a n d dist e nsi o n of b o w el filli n g a ge nts 
 Bl o o d sa m pli n g f or electr ol yt e assess me nt ( pre-, 1, 2, 4, 6, 8 h) 
 Rec or di n g of c o m plia nce 
1 1. 1. 4  Bl o o d s a m pli n g visit ( Visit 4: D ay 1 5) 
D uri n g t his visit t h e f oll o wi n g assess me nt will be perf or me d: 
 Rec or di n g of c o n c o mita nt treat me nts 
 Rec or di n g of A Es 
 Bl o o d sa m pli n g f or electr ol yt e assess me nt ( 2 4 h) 
1 1. 1. 5  F- U a n d e arl y ter mi n ati o n visit ( Visit 5: Visit 2 2 d a ys) 
D uri n g t his visit t h e f oll o wi n g assess me nt will be perf or me d: 
 Rec or di n g of c o n c o mita nt treat me nts 
 Rec or di n g of A Es 
1 1. 2  Assess me nt d escri pti o ns  
1 1. 2. 1  S u bject De m o gr a p hy 
S u bject de m o gra p h y c o nsists of date of birt h, se x, h ei g ht a n d wei g ht. 
1 1. 2. 2  Me dic al Hist ory 
F or t he d o c u me ntati o n of t he me dical hist or y, a n y pre vi o us a n d c o n c o mita nt diseases 
wit hi n t he last 2 years bef ore scree ni n g will be d o c u me nte d i n t he C R F. 
T he me dical hist or y will b e o bt ai ne d b y as ki n g t he s u bject a n d b y i ns pecti n g his/ her 
me di cal re c or ds if a v aila bl e. 
F or statisti cal a nal ysis, all pre vi o us a n d c o nc o mita nt diseases will b e c o de d wit h Me dical 
Dicti o n ar y f or Re g ul at or y Acti vities ( Me d D R A), t he versi o n of w hi c h will be pr o vi de d i n 
t he tri al re p ort. 
1 1. 2. 3  Pre g n a ncy Test 
I n w o me n of c hil d beari n g p ote ntial, uri ne pre g n a nc y test will b e perf or m e d at scree ni n g. 

S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
3 2 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
1 1. 2. 4  C o nc o mit a nt Me dic ati o n 
I nf or mati o n o n c o nc o mit a nt treat me nt will c o m prise all c o nc o mita nt t hera pies at t he 
M R E e xa mi n ati o n a n d u ntil t he e n d of treat me nt visit 2, bl o o d sa m pli n g. Acce pt a ble 
c o nc o mita nt treat m e nt o pti o ns are descri be d i n S ecti o n 1 0. 1 . 
1 1. 2. 5  Assess me nt of S afety 
A Es will b e rec or de d fr o m t he ti me of i nf or me d c o nse nt ( Da y 0) u ntil t h e f oll o w- u p visit 
or earl y ter mi nati o n visit. 
F or safet y reas o ns, s u bjects will b e c o ntacte d wit hi n 2 t o 4 d a ys after t h e M R E 
e xa mi nati o n b y t h e i n v esti gat or a n d as k e d a b o ut occ urre nce of a n y a d vers e e ve nt. N o 
ot h er f oll o w- u p is pla n ne d. 
Detail e d i nstr ucti o ns re g ar di n g A E ha n dli n g, m o nit ori n g a n d re p orti n g are pr o vi de d i n 
S ecti o n 0 ( A d vers e E ve nts).  
1 1. 2. 6  Electr olyte assess me nt 
Plas ma p otassi u m, s o di u m, p h os p h at e, a n d cal ci u m, as well as i o ni ze d calci u m bl o o d 
c o nce ntrati o n le vels will be m o nit ore d o ver 2 4 h o urs fr o m j ust bef ore ( bas eli n e) t he 
s u bj ect starts dri n ki n g L u m e nti n ®  4 4.  Bl o o d sa m ples will be dra w n at b aseli n e ( T 0 h), 
a n d t he n at 1 h o ur ( T 1 h), 2 h o urs ( T 2 h), 4 h o urs ( T 4 h), 6 h o urs ( T 6 h), 8 h o urs ( T 8 h) a n d 
at 2 4 h o urs ( T 2 4 h).  
A n I V a nte c u bital ca n n ula will b e place d f or pre- bl o o d sa m pl es a n d use d d uri n g t he first 
8 h i n cl u di n g a d mi nistrati o n of G d d uri n g t he M R E pr oce d ure. T hereafter it will b e 
discar de d. Bl o o d sa m pli n g o n t he f oll o wi n g da y after ( 2 4 h ti me p oi nt) will be dra w n 
wit h o ut a ca n n ula. 
Electr ol yt e bl o o d sa m pl es will be ta ke n, ha n dl e d, a n d a nal yse d acc or di n g t o st a n dar d 
pr oce d ur es at t he cli nic. T he la b orat or y will pr o vi d e n or mal ra n g es. 
1 1. 2. 7  M R E e x a mi n ati o n 
Pre parati o n bef ore M R E: S u bjects will be fasti n g ( 2 d ecilitres of cl ear w ater is all o we d) 
f or at least si x h o urs pri or t o t h e M R E pr oce d ure. 
T he M R E-e xa mi nati o n will ta ke a p pr o xi m atel y 4 0 mi n utes. T he M R-e xa mi nati o n will 
n ot b e perf or me d if t h e s u bject has n ot bee n a ble t o dri n k at least 1. 1 L of L u me nti n ®  4 4. 
Br oa dl y, M R E is a s ca n ni n g tec h ni q ue f or creati n g detaile d i ma ges of p arts of t he h u ma n 
b o d y, usi n g a str o n g ma g n etic fiel d a n d ra di o wa v es. It is base d o n t he ma g netisati o n 
pr o p erti es of at o mi c n uclei. A p o werf ul, u nif or m, e xter nal ma g n eti c fiel d is e m pl o ye d t o 
ali g n t he pr ot o ns t hat are n or mall y ra n d o ml y orie nte d wit hi n t h e water n u cl ei of t h e b o d y 
part e xa mi ne d. T his ali g n m e nt ( or ma g netisati o n) is disr u pt e d b y i ntr o d ucti o n of a n 

S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
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1 5 t h N o ve m ber 2 0 2 2 
e xter nal Ra di o Fre q u e nc y ( R F) w a ve e ner g y. T h e n uclei ret ur n t o t heir resti n g ali g n me nt 
t hr o u g h vari o us rela xati o n pr ocesses a n d i n d oi n g s o e mit R F e ner g y. Tiss u es are 
c haracterise d b y t w o differe nt rela x ati o n ti mes, of w hic h T 1, t he l o n git u di n al rela xati o n 
ti me, det er mi nes t h e rate at w hic h e xcite d pr ot o ns ret ur n t o e q uili bri u m. It is a m eas ure of 
t he ti me ta ke n f or s pi n ni n g pr ot o ns t o reali g n wit h t he e xt er nal ma g n etic fi el d. T he 
c o ntrast a n d bri g ht n ess of t h e i ma ge are pre d o mi n at el y deter mi ne d b y T 1 pr o perties of 
tiss ue. 
D uri n g a n M R E-e x a mi nati o n, t he s u bject will b e as ke d t o lie pr o ne o n a m o va bl e ta bl e 
t hat will sli de i nt o a d o u g h n ut-s h a pe d, d ee p o pe ni n g a n d ce ntre d f or s ca n ni n g t he s mall 
b o wel. As part of t h e pr oce d ure a str o n g ma g netic fiel d will be ge ner at e d ar o u n d t he 
s u bj ect, a n d p ulsati n g ra di o wa ves will be direct e d at t h e b o d y. Beca us e of l o u d t h u m pi n g 
a n d ta p pi n g n oises d uri n g t h e sca n t he s u bject will be gi v e n hea d p h o n es t o list e n t o m usic 
or ear pl u gs t o hel p bl o c k t h e s o u n d. T he s u bject will be a ble t o c o m m u nicate wit h t h e 
tec h ni ci a n w h o gi v es i nstr ucti o ns d uri n g t h e test. T he c o ntrast a g e nt Claris ca n®  ( 0. 1 
m m ol/ k g) a n d t he m uscle rela xa nt B usc o pa n ®  ( 4 0 m g) (t o re d uce b o wel m otilit y) will be 
a d mi nistere d I V. Clarisca n a n d B usc o pa n ca n be re place d  wit h c o m para ble pr o d uct 
acc or di n g t o t h e sta n d ar dise d pr oce d ures at t he cli ni c. T he s pecific details of t h e M R E-
s yste m use d will be n ote d i n t h e C R F.  
1 1. 3  O utc o me assess me nts 
1 1. 3. 1  Pri m ary o ut c o mes 
All M R E i m a ges will be e val uate d b y o ne e x p ert ra di ol o gist. O nl y o ne assess me nt of 
eac h M R E e x a mi nati o n will be perf or me d.  
T he pri mar y e n d p oi nt is t he vis ual e val uati o n of t h e M R E i ma ges acc or di n g t o t he 
f oll o wi n g p ara meters:  
 
M otilit y: M R E e xa mi nati o ns wit h L u me nti n
®  4 4 will be sc ore d wit h res pect t o m otilit y 
stat us base d o n a 5- gra de d scale, as f oll o ws: 
1.  N o m otilit y c o ul d b e assesse d 
2.  M otilit y is assesse d t o s o me d e gree b ut less g o o d t h a n c o n ve nti o nal M R E 
3.  M otilit y is assesse d t o sa me de gree as c o n v e nti o nal M R E 
4.  M otilit y is assesse d s o me w hat b etter t ha n c o n v e nti o nal M R E 
5.  M otilit y is assesse d better t ha n c o n ve nti o nal M R E 
M otilit y s h o ul d be e v al u ate d as a w h ol e i n t h e s pe cific ci ne- se q ue n ces a n d res ulti n g 
i n o n e or di nal sc ore 1- 5. 
Artef a cts: M R E e xa mi n ati o ns wit h L u me nti n
®  4 4 will be sc ore d wit h res pect t o artefacts 
base d o n a 5- gra d e d scale, as f oll o ws:  

S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
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1 5 t h N o ve m ber 2 0 2 2 
1.  S e vere det eri orati n g artefacts i n t he i nterfa ce b et w ee n t he l u me n a n d wall 
2.  Dist ur bi n g artefacts i n t he i nterface b et wee n t he l u me n a n d wall l ess g o o d 
c o m pare d t o c o n v e nti o nal M R E 
3.  Me di u m artefacts i n t h e i nterfa ce bet w ee n t h e l u m e n a n d wall, sa me as f or 
c o n v e nti o nal M R E 
4.  S mall artefacts t hat gi ve mi ni m al bri g ht e d ges i n t h e i nterface bet wee n t he l u me n 
a n d wall, s o me w h at better t h a n c o n ve nti o nal M R E 
5.  N o art efacts a n d b etter t ha n c o n v e nti o nal M R E 
Artefacts s h o ul d be e v al u ate d as a w h ol e i n all se q ue nces a n d res ulti n g i n o ne or di nal 
sc ore 1- 5. 
M uc os al e v al u ati o n: M R E e xa mi nati o ns wit h L u me nti n
®  4 4 will be sc ore d wit h res pect 
t o m u c osal stat us bas e d o n a 5- gra d e d scale, as f oll o ws: 
1.  N o m uc osal f ol ds are see n 
2.  S o me s mall m u c osal f ol ds ca n be discri mi n ate d 
3.  M u c osal f ol ds ca n b e discri mi n ate d, sa me as f or c o n ve nti o nal M R E 
4.  S mall m u c osal f ol ds ca n be discri mi nate d, s o me w h at b etter t ha n f or c o n ve nti o nal 
M R E 
5.  M u c osal f ol ds are see n i n d etail a n d better t ha n c o n v e nti o nal M R E 
M uc osal e val uati o n a) c or o n al a n d b) a xial T 1 gra di e nt-ec h o wit h G d s h o ul d be d o n e a n d 
res ulti n g i n o ne or di n al sc ore 1- 5. 
O v er all di a g n ostic i m pressi o n: M R E e xa mi nati o ns wit h L u me nti n
®  4 4 will be gra de d 
f or gl o bal q ualit y of t h e i nf or mati o n o btai n e d wit h s pecial refere nce t o dia g n ostic 
p ur p oses, as f oll o ws: 
1.  P o or dia g n ostic q u alit y 
2.  Me di u m dia g n osti c q ualit y, bel o w c o n v e nti o nal M R E 
3.  G o o d dia g n osti c q ualit y, sa me as f or c o n ve nti o nal M R E 
4.  Ver y g o o d dia g n ostic q u alit y, s o me w hat better t ha n c o n ve nti o nal M R E 
5.  E xcelle nt dia g n osti c q ualit y, better t ha n c o n v e nti o nal M R E 
T he q ualit y of t he w h ole e xa mi nati o n a n d w hat t h e i m pressi o n is f or usi n g t he 
e xa mi nati o n f or dia g n osti c p ur p oses will be gra d e d. 
1 1. 3. 2  S ec o n d ary o utc o mes 
Electr ol yte c h a n g es: C ha n ges i n electr ol ytes i n t h e bl o o d of eac h s u bj ect will b e 
e val uate d b y c o m p ari n g basel Plas ma c o nc e ntrati o n was meas ur e d o v er 2 4 h fr o m b ef ore 

S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
3 5 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
a d mi nistarti o n of L u me nti n 4 4 ( T 0 h) t 0 2 4 h o urs p ost a d mi nistrati o n ( T 2 4 h) i n e ( pre- 
L u me nti n ®  4 4 oral i nt a ke) a n d ti me p oi nts u p t o 2 4 h o urs p ost L u me nti n®  4 4 oral i nt a ke.  
B o wel filli n g p r o p erties: E xte nsi o n a n d diste nsi o n will be e val uate d i n e ac h of fi ve 
selecte d s u b-se g me nts of t h e s mall b o wel. All i ma g es will be e val uate d b y t h e 
i n v esti g at or wit h res p ect t o h o w well t h e s mall b o wel is fille d fr o m t h e b o wel t hr o u g h t o 
t he ter mi n al ile u m (e xt e nsi o n) a n d h o w well it is dist e n de d ( diste nsi o n) b y L u me nti n®  4 4. 
T he s m all b o wel will be di vi de d i n d u o d e n u m, jej u n u m, pr o xi mal il e u m, distal ile u m a n d 
ter mi n al ile u m. B ot h v aria bles will b e j u d ge d o n a scal e fr o m 1 t o 5, as f oll o ws: 
 E xte nsi o n: 1 is n o filli n g a n d 5 is fille d c o m pletel y 
 Dist e nsi o n of t he se g me nt of s mall b o wel:  1 is n o diste nsi o n a n d 5 is o pti mal 
diste nsi o n 
 
S afet y o utc o mes: All a d verse e v e nts i n t his st u d y will b e c ollecte d a n d pr o cesse d i n 
acc or d a nce wit h I C H- G C P a n d n ati o nal a n d l ocal la ws a n d r e g ulati o ns. I n li ne wit h t hese, 
t he I n v esti g at or is res p o nsi ble f or re p orti n g S eri o us A d verse E v e nts ( S A Es) t o S p o ns or 
wit hi n t he a p pr o priate ti meli nes. If re q uire d, t h e I n vesti g at or is als o res p o nsi ble f or 
n otif yi n g t he a p pr o pri ate l o cal et hics c o m mittee of S A Es per t he g ui deli nes of t h e 
I nstit uti o n a n d i n acc or da nce wit h af ore me nti o ne d la ws a n d re g ul ati o ns. Det aile d 
descri pti o n o n ha n dli n g, m o nit ori n g a n d re p orti n g A Es is pr o vi de d i n S ecti o n 0 .   
 
 

S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
3 6 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
1 2  A D V E R S E E V E N T S 
A n y u nt o war d me di cal o cc urre nce i n a s u bj ect or cli nical trial s u bject a d mi nistere d a 
me di ci nal pr o d uct a n d w hi c h d o es n ot necess aril y h a ve a ca usal rel ati o ns hi p wit h t his 
treat me nt. U nt o war d me dical o cc urre n ces occ urri n g pri or t o t he M RI/ M R E assess me nt 
will n ot be re p orte d as a n a d verse e ve nt. All A Es o cc urri n g t hr o u g h o ut t h e trial will be 
rec or d e d a n d f oll o w e d.  
C o m me nt:  A n A E ca n t h eref ore be a n y u nfa v o ura ble a n d u ni nte n de d si g n (i n cl u di n g a n 
a b n or mal l a b orat or y fi n di n g), s y m pt o m, or disease te m p orall y ass ociat e d wit h t h e us e of 
a n I M P, w het her or n ot c o nsi d ere d rel at e d t o t he I M P. 
1 2. 1. 1  A dverse Re acti o n 
All u nt o war d a n d u ni nte n de d res p o nses t o a n i n v esti gati o nal me di ci nal pr o d uct relate d t o 
a n y d ose a d mi nistere d. 
C o m me nt:  All A Es j u d ge d b y eit h er t h e re p orti n g I n v esti gat or or t he S p o ns or as h a vi n g a 
reas o na bl e ca us al relati o ns hi p t o a me dici nal pr o d uct q u alif y as a d v erse reacti o ns. T he 
e x pressi o n reas o n a ble ca usal relati o ns hi p mea ns t o c o n ve y i n g e neral t hat t h ere is 
e vi de nce or ar g u m e nt t o s u g gest a ca us al relati o ns hi p. 
1 2. 1. 2  U ne x pect e d A dverse Re a cti o n 
A n a d vers e reacti o n, t he nat ure or se v erit y of w hic h is n ot c o nsiste nt wit h t he a p pli ca ble 
pr o d uct i nf or mati o n (e. g., I B f or a n u na ut h orise d I P or s u m mar y of pr o d uct 
c haracteristics f or a n a ut h orise d pr o d uct). 
C o m me nt:  W he n t he o utc o me of t he a d v erse reacti o n is n ot c o nsist e nt wit h t he a p plica ble 
pr o d uct i nf or mati o n t his a d v erse reacti o n s h o ul d be c o nsi dere d as u ne x p ect e d. 
1 2. 1. 3  S eri o us A d verse Eve nt 
A n y u nt o war d me di ci nal occ urre nce or effect t h at at a n y d ose: 
 Res ults i n deat h 
 Is life-t hreate ni n g 
 Re q uires h os pitalisati o n or pr ol o n gati o n of e xisti n g h os pitalisati o n 
 Res ults i n persiste nt or si g nifica nt disa bilit y or i nca pacit y 
 Is a c o n ge nital a n o mal y or birt h defect 
C o m me nts: Life-t hreate ni n g i n t he defi niti o n of a n S A E or seri o us a d verse reacti o n refers 
t o a n e ve nt i n w hic h t he s u bject was at ris k of deat h at t he ti me of e ve nt; it d oes n ot refer 
t o a n e ve nt w hi c h h y p ot h eticall y mi g ht ha ve ca us e d deat h if it was m ore s e v ere. 

S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
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1 5 t h N o ve m ber 2 0 2 2 
Me dical j u d ge me nt s h o ul d be e xercise d i n d eci di n g w het h er a n A E/reacti o n is seri o us i n 
ot h er sit u ati o ns. I m p orta nt A Es/reacti o ns t hat are n ot i m m e di atel y life-t hreate ni n g or d o 
n ot res ult i n deat h or h os pit alisati o n b ut ma y je o par dise t h e s u bj ect or ma y re q uire 
i nter ve nti o n t o pre v e nt o ne of t he ot her o ut c o mes liste d i n t he defi niti o n a b o ve, s h o ul d 
als o be c o nsi d ere d seri o us. 
1 2. 2  Re p orti n g of A d verse E v e nts 
All trial s u bjects will b e caref ull y m o nit ore d f or t he occ urre n ce of A Es d uri n g t h e trial 
peri o d, fr o m start of i nta ke of t h e first d ose of c o ntrast a ge nt u ntil t he f oll o w- u p visit. 
Als o, tele p h o ne i nter vie ws will b e ma de 2 d a ys after M R E assess me nt t o i n vesti gate if 
a n y A Es o cc urre d d uri n g t he first da ys after t h e e xa mi nati o n. A n y pre g na ncies occ urri n g 
i n t he s a me trial p eri o d will be re p orte d a n d f oll o we d.  
Re p ort e d A Es will be f oll o we d u p (see Se cti o n 1 2. 5 bel o w). T he I n vesti gat or will c ollect 
A Es wit h a n o n-lea di n g q uesti o n s uc h as “ ha v e y o u e x perie nce d a n y n e w h ealt h pr o ble ms 
or w orse ni n g of e xisti n g c o n diti o ns” as well as re p orti n g e ve nts directl y o bser ve d or 
s p o nta ne o usl y v ol u nteere d b y s u bjects. 
Clearl y rel ate d si g ns, s y m pt o ms a n d a b n or mal dia g n ostic pr o ce d ure res ults s h o ul d be 
gr o u pe d t o get her a n d re p orte d as a si n gle dia g n osis or s y n dr o me w he n e ver p ossi ble. 
All A Es i ncl u di n g b ut n ot li mit e d t o e ve nts re p orte d b y t he s u bject, or re p orte d i n a ns wer 
t o a n o pe n q uesti o n b y t he I n vesti gat or or m e m ber of t his tea m, w hi c h fall i nt o a n y of t he 
a b o v e d efi niti o ns m ust be rec or de d as a n A E i n t h e C R F a n d s h o ul d i ncl u d e t he f oll o wi n g 
i nf or mati o n: 
 Brief descri pti o n of t he e ve nt ( dia g n osis) 
 Start date (a n d ti me, if r el e va nt) 
 St o p date (a n d ti me, if rele va nt) 
 S e verit y 
 Acti o n ta ke n re gar di n g trial treat me nt 
 O pi ni o n o n ca usalit y 
 S eri o us ness 
 O utc o me 
A Es will b e c o de d wit h M e di cal Dicti o n ar y f or R e g ul at or y Acti vities ( Me d D R A), t he 
versi o n of w hi c h will be pr o vi de d i n t he trial re p ort. 
1 2. 2. 1  S everity 
S e verit y descri b es t h e i nte nsit y of a n e ve nt, a n d will be assesse d as: 

S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
3 8 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
Mil d : T h e A E d oes n ot i nt erfere i n a si g nifica nt ma n ner wit h t h e s u bject’s n or mal 
f u ncti o ni n g le vel. It ma y be a n a n n o y a nce. 
M o der ate:  T he A E pr o d u ces s o me i m pair me nt of f u ncti o n b ut n ot hazar d o us t o h ealt h. It 
is u nc o mf orta ble a n d/ or a n e m barrass me nt. 
S e vere:  T h e A E pr o d uces si g nifica nt i m pair me nt of f u ncti o ni n g or i n ca pacitati o n a n d/ or 
it is a hazar d t o t he s u bj ect. 
If a n A E c ha n ges i n s e verit y, t he w orst se verit y s h o ul d b e re p orte d. 
1 2. 2. 2  C a us ality 
Ca usalit y will be assesse d as: 
Pr o b a ble: A cli ni cal e ve nt, i n cl u di n g la b orat or y test a b n or malit y, wit h a reas o n a bl e ti me 
se q u e nce t o a d mi nistrati o n of t h e dr u g, u nli kel y t o be attri b ut e d t o c o n c urre nt disease or 
ot h er dr u gs or c h e micals, a n d w hic h f oll o ws a cli nicall y reas o n a ble res p o ns e o n 
wit h dra wal ( dec halle n g e). Rec halle n ge i nf or mati o n is n ot re q uire d t o f ulfil t his defi niti o n. 
P ossi ble: A cli ni cal e ve nt, i n cl u di n g la b orat or y test a b n or malit y, wit h a reas o n a bl e ti me 
se q u e nce t o a d mi nistrati o n of t h e dr u g, b ut w hi c h c o ul d als o be e x plai ne d b y c o nc urre nt 
disease or ot her dr u gs or c he mi cals. I nf or mati o n o n dr u g wit h dra wal ma y b e lac ki n g or 
u nclear. 
U nli k el y: A cli ni cal e ve nt, i n cl u di n g la b orat or y test a b n or malit y, wit h a te m p oral 
relati o ns hi p t o dr u g a d mi nistrati o n w hic h ma kes a ca usal relati o ns hi p i m pr o ba ble, a n d i n 
w hic h ot her dr u gs, c he micals or u n derl yi n g disease pr o vi de pla usi ble e x pla nati o ns. 
1 2. 3  F oll o w- u p of S u bj ects after A d verse E ve nts 
A Es t hat are s eri o us or t h ose t h at t he i n vesti gat or assesses as rele va nt t o f oll o w fr o m a 
trial pers pecti v e will be f oll o we d u ntil t he y are rec o vere d, st a bilis e d, or rec o vere d wit h 
se q u elae. T h e date a n d o utc o me will b e rec or de d o n t h e A E f or m i n t h e C R F. Ot h er 
o n g oi n g A Es will n ot be f oll o we d wit hi n t he trial after t he d ate of t he f oll o w- u p visit. 
1 2. 4  A b n o r m al L a b o r at or y V al ues 
Ot h er t ha n electr ol ytes, s afet y l a b orat or y para met ers will n ot be assesse d i n t his trial. 
1 2. 5  Re p orti n g of Seri o us A d v ers e E v e nts 
T he I n vesti g at or is res p o nsi ble f or e ns uri n g t h at all S A Es are re p orte d t o t he S p o ns or 
i m me diatel y, b y e- mail ( preferre d) or f a x, b ut i n a n y e ve nt n o l ater t h a n  2 4 h o urs of a n y 
site staff bec o mi n g a ware of t he e v e nt. All A Es t h at meet t he criteria f or S A E re q uire t he 
c o m pleti o n of a st u d y s pecific S A E F or m ( or A d diti o nal S afet y I nf or mati o n ( A SI) F or m). 

S p o ns or: L u me nt A B  
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T his a p plies t o all S A Es, w het her t he y were c o nsi dere d t o be rel at e d t o t he st u d y 
treat me nt or n ot.  
T he f oll o wi n g i nf or mati o n is m a n d at or y  f or t he i nitial re p ort: 
 S u bject trial i de ntificati o n data (I D) 
 Trial treat me nt 
 Start date (ti me, if rele v a nt) of t h e trial treat m e nt 
 Brief descri pti o n of t he e ve nt ( dia g n osis) 
 Start date (ti me, if rele v a nt) of t h e e ve nt 
 S eri o us ness criteria 
 Ca usalit y assess me nt 
T he I n vesti g at or m ust re p ort all S A Es t o S p o ns or i m m e di at el y, i. e., wit hi n 2 4 h o urs ( via 
e mail or fa x) of lear ni n g of its occ urre nce. F or t his re p orti n g, a n S A E F or m ( pr o vi d e d i n 
t he I n v esti g at or File) nee ds t o b e c o m pl et e d. F oll o w- u p i nf or mati o n a b o ut a pre vi o usl y 
re p orte d S A E m ust als o b e re p ort e d t o S p o ns or wit hi n 2 4 h o urs of recei vi n g t he 
i nf or mati o n. T his f oll o w- u p data m ust be pr o vi de d o n a n A SI F or m.  
If a S A E o cc urre d aft er si g ni n g i nf or me d c o nse nt, b ut bef ore st u d y treat me nt a n d t he 
s u bj ect c o nti n ues o n st u d y, a S A E m ust als o b e e nt ere d o n t h e rele va nt M e dical Hist or y 
pa ge of t he C R F. 
T he S A E re p ort s h o ul d pr o vi de a detaile d d escri pti o n of t he A E a n d s h o ul d i n cl u de 
a n o n y mise d c o pies of h os pit al rec or ds a n d ot h er rele va nt d o c u me nts.  
All S A Es will nee d t o be f oll o we d acti vel y u ntil res ol uti o n or sta bilisati o n. T he a b o v e is 
als o a p pli ca ble t o f oll o w- u p S A E i nf or mati o n. 
T he S p o ns or is res p o nsi ble f or i nf or mi n g t he C o m pete nt A ut h orities, t h e E ur o pea n 
Me dici nes A ge nc y ( E M A) a n d Et hics C o m mitt ees of a n y i n di vi d ual case re p orts of S A Es 
t hat are d eter mi n e d t o be re p ort a ble b y t h e s p o ns or (i.e., a d v erse e ve nts c o nsi dere d as 
seri o us u ne x pecte d s us pecte d a d v erse reacti o ns [ S U S A Rs]). S U S A Rs will b e distri b ute d 
b y t h e S p o ns or’s p h ar mac o vi gila nce tea m wit hi n 7- 1 5 w or ki n g d a ys t o t h e E M A 
( E u dra Vi gila nc e) a n d c o ncer n e d C o m pete nt A ut h oriti es a n d Et hi cs C o m mittees, 
acc or di n g t o l o cal re g ulati o ns. T h e i n vesti g at or will be n otifie d of safet y iss ues / S U S A Rs 
acc or di n g t o c urre nt le gislati o n. 
T he s p o ns or is re q uire d b y la w t o re p ort t o t h e healt h a ut h oriti es i n a writte n safet y 
re p ort: 1) all fatal or life-t hreate ni n g S U S A Rs wit hi n s e ve n ( 7) cale n dar da ys of i nitial 
n otificati o n; a n d 2) all ot her S U S A Rs wit hi n fiftee n ( 1 5) cale n d ar d a ys of i nitial 
n otificati o n. 

S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
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1 2. 6  Prec a uti o ns/ O ver d ose 
Ris ks ass o ciate d wit h i nt a ke of oral c o ntrast a ge nts i n cl u de d ys p ha gia wit h as pirati o n a n d 
sec o n d ar y p n e u m o nia. Alt h o u g h pati e nts wit h ac ute pr o ble ms are e xcl u de d, a pre-
e mer ge n c y s mall b o wel stat us mi g ht be a g gra vate d t o a n esta blis h e d ile us b y i n g esti n g a 
lar ge v ol u me. Oral c o ntrast a ge nts s h o ul d n ot b e gi ve n t o s u bc o nsci o us p atie nts, t o t h ose 
wit h s wall o wi n g dis or ders, or a n ac ute a b d o me n.  
K n o w n se nsiti vit y or aller g y t o c o ntrast a ge nt i n gre die nts are e xcl usi o n crit eria i n cli ni cal 
st u dies. H o we ver, u n k n o w n se nsiti vities or aller gies mi g ht ca use reacti o ns t h at ma y nee d 
t o be me dicall y treat e d.  
I ntra ve n o usl y a d mi nist ere d G d m a y c a use aller gi c reacti o n of v ari o us se verit y fr o m a 
mil d r us h t o i nt e nsi v e care u nit treat me nt. T his is es peciall y tr ue f or t h ose wit h all er gi c 
reacti o ns t o a c o ntrast a g e nt earlier i n life. Aller gic reacti o n ma y be tri g ge d i n t h ose wit h 
ast h matic br o nc hitis a n d treate d wit h bet a- bl oc kers. R o uti nes f or ha n dli n g t hese cases are 
well k n o w n t o t h e staff w hic h is re g ul arl y trai n e d i n d eali n g wit h e mer ge n c y cases. 
E q ui p me nt f or e mer ge nc y care treat m e nt is a v aila ble at t he cli ni c a n d t he cli ni c is l ocate d 
i n cl ose pr o xi mit y t o t h e h os pit al e mer ge nc y car e de part me nt. Neit her i o di ne n or G d 
s h o ul d be a d mi nistere d t o p atie nts wit h se vere ki d ne y fail ure.  
 
 

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1 3  S T A T I S T I C A L M E T H O D S 
1 3. 1  Ge ner al st atisti c al c o nsi der ati o ns 
N o statistical t ests will be c o n d ucte d. C o nfi d e nce i nter vals ma y be c o nstr u ct e d a n d will 
t he n be 2-si de d a n d of 9 5 % c o nfi de n ce.  
C o nti n u o us data will be s u m marise d usi n g descri pti ve statisti cs ( N, mea n, me dia n, 
sta n dar d d e viati o n, mi ni m u m a n d ma xi m u m). C ate g orical data will be s u m marise d b y 
fre q ue n c y ta bl es ( n u m b ers a n d perce nt a ges).  
U nless ot her wise state d, all a nal yses will be d o n e o n o bser ve d cases wit h o ut a n y 
s u bstit uti o n of missi n g val ues. 
1 3. 2  S a m ple Si ze  
A t ot al of 1 0 f ull y e val ua ble h ealt h y v ol u nteers will be i n cl u de d i n t he trial. T h e n u m ber 
of s u bj ects is c o nsi dere d t o b e e n o u g h t o dra w cli nical c o ncl usi o ns a n d is n ot base d o n 
a n y mat he matical gr o u n ds. 
1 3. 3  A n al yses Sets 
All s u bjects w h o ha ve f ulfill e d t he trial will be i n cl u de d i n t he statistical e val u ati o n.  
1 3. 4  Descri pti o n of St atistic al A n al yses 
A c ollecte d d ata will be s u m marise d usi n g descri pti ve statisti cs a n d c o nfi de nce i nter vals. 
N o statistical t ests are pla n ne d t o be c o n d u ct e d. 
1 3. 5  D at a c ollecti o n 
T he d ata i n t his trial will be rec or de d o n pa per C R Fs, as per data ma n a ge m e nt a n d q ualit y 
ass ura n ce pr oce d ures des cri b e d i n S ecti o n 0 . W he n t he data o n t he C R Fs h as b ee n 
verifie d ( b y t h e st u d y m o nit or) a gai nst s o urce data t he y will b e se nt f or data e ntr y. All 
C R Fs will be si g ne d b y t he pri n ci p al i n vesti g at or. 
Data e ntr y will b e c o n d u cte d usi n g t h e v erifie d C R Fs as s o urce. All data e ntr y will be 
c o ntr oll e d usi n g pr o of rea di n g. 
W he n data fr o m all s u bje ct’s C R Fs are e nt er e d i nt o t he data base a clea n fil e meeti n g will 
be h el d. At t h at meeti n g it will be deci d e d if a n y of t h e s u bj ects s h o ul d b e e xcl u de d fr o m 
statistical a nal ysis. 
W he n it has bee n d eci de d w hic h s u bjects s h o ul d be i n cl u de d i n t h e data a nal yses, t h e trial 
data base will be l o c k e d a n d a c o p y of t he it will be se nt f or st atisti cal a nal yses. 
 

S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
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1 5 t h N o ve m ber 2 0 2 2 
 
1 4  E T H I C S 
1 4. 1  I n de pe n de nt Et hics C o m mittee (I E C) 
T he cli nical trial m ust b e a p pr o ve d b y/recei v e fa v o ura ble o pi ni o n fr o m rele va nt 
I n d e pe n de nt Et hics C o m mittees (I E Cs) pri or t o e nr ol me nt of s u bjects. 
A n y a me n d me nts t o t he a p pr o ve d cli ni cal tri al m ust li ke wise, as re q uire d, be a p pr o ve d 
b y/recei v e fa v o ura ble o pi ni o n fr o m rel e va nt I E Cs pri or t o i m ple me ntati o n. 
T he a p pr o priate r e g ulat or y a ut h orit y(i es) m ust b e n otifie d of/a p pr o ve t he cli nical tri al, as 
re q uire d. 
1 4. 2  Et hic al C o n d uct of t he Tri al 
T his cli nical st u d y was d esi g ne d a n d s hall be i m ple me nte d a n d re p orte d i n acc or d a nc e 
wit h t h e pr ot o c ol, et hical pri nci ples lai d d o w n i n t he Decl arati o n of H elsi n ki a n d t he 
I nter nati o nal C o nfere n ce o n H ar m o nizati o n (I C H) Har m o nize d Tri partite G ui deli nes f or 
G o o d Cli nical Practice ( G C P).  
If a n y c h a n g es t o t he pr ot oc ol are re q uire d, t he pr ot o c ol m ust be a me n de d (see Secti o n 
1 6. 2 ).  
1 4. 3  S u bject I nf or m ati o n a n d C o nse nt 
All s u bjects will recei ve writte n a n d ver b al i nf or mati o n re gar di n g t he trial b ef ore a n y 
trial-relate d pr oce d ures are perf or me d. T his i nf or mati o n will e m p h asise t h at partici pati o n 
i n t he trial is v ol u ntar y a n d t hat t h e s u bj ect ma y wit h dra w fr o m t h e tri al at a n y ti me a n d 
f or a n y reas o n. All s u bjects will be gi ve n t he o p p ort u nit y t o as k q u esti o ns a b o ut t he trial 
a n d will be gi v e n s ufficie nt ti me t o deci de w het her t o p arti ci pate i n t h e trial. 
T he p atie nt’s si g ne d a n d date d i nf or m e d c o nse nt t o partici p at e i n t he trial will be o btai n e d 
p ri or  t o a n y trial relat e d pr oce d ure is bei n g carrie d o ut. T he c o nse nt f or m m ust als o b e 
si g n e d b y t h e pers o n w h o c o n d uct e d t he i nf or me d c o nse nt disc ussi o n 
T he c o nse nt i ncl u d es i nf or m ati o n t hat dat a will be rec or de d, c ollecte d, pr o cesse d a n d 
ma y be tra nsf err e d t o E ur o pea n Ec o n o mic Area ( E E A) or n o n- E E A c o u ntri es. I n 
acc or d a nce wit h t he E U ge neral d ata pr ote cti o n re g ulati o n 2 0 1 6/ 6 7 9 ( G D P R), t he d ata 
will n ot i de ntif y a n y pers o ns ta ki n g part i n t h e tri al. 
A c o p y of t he s u bje ct i nf or mati o n i ncl u di n g t he si g ne d i nf or me d c o ns e nt f or m will be 
pr o vi d e d t o t h e s u bject, f or t heir rec or ds. 

S p o ns or: L u me nt A B  
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Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
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1 4. 4  S u bject D at a Pr otecti o n 
All i nf or mati o n c o ntai ni n g pers o nal d ata will be h a n dle d i n acc or da n ce wit h S w e dis h 
data pr ot ecti o n l e gisl ati o n a n d wit h t he E U ge neral d ata pr otecti o n re g ulati o n 2 0 1 6/ 6 7 9 
( G D P R). 
1 4. 5  Ot her Et hi c al a n d Re g ul at or y Iss u es 
If a si g nifica nt safet y iss u e is i de ntifi e d, eit h er fr o m a n i n di vi d u al case re p ort or re vie w of 
a g gre gat e d ata, t he n t h e S p o ns or will iss u e pr o m pt n otificati o n t o all parties: Re g ulat or y 
A ut h orities, I n vesti gat ors a n d I E Cs. 
A si g nifica nt safet y iss ue is o ne t hat h as a si g nifica nt i m p act o n t h e c o urs e of t he cli nical 
trial or pr o gra m (i n cl u di n g t he p ot e nti al f or s us pe nsi o n of t h e trial pr o gra m or 
a me n d me nts t o pr ot o c ols) or warra nts i m m e diate u p date of i nf or me d c o nse nt. 
1 4. 6  Et hic al C o nsi der ati o n st ate me nt 
O ur n e wl y i n ve nte d p er oral a ge nt f or b o w el filli n g pri or t o C T or M R E of t h e a b d o me n 
has re veale d a g o o d p ot e ntial t o i m pr o v e i ma gi n g of t h e b o wel w all i n c o m paris o n t o 
c urre ntl y use d c o ntract i ma gi n g a ge nts. I n a d diti o n, bei n g a bl e t o use t he s a me a ge nt f or 
b ot h t h ese pr oce d ures will offer o p erati o nal be n efits t o dia g n ostic cli ni cs. 
P ote ntial b e nefits f or f ut ure p atie nts i n cl u de first a n d f ore m ost M R E i m a g es easier t o 
i nter pret, t h er e b y facilitati n g dia g n ostics of earl y a n d hit hert o sile nt disease, a n d re d uci n g 
t he ris k of misrea di n g. Sec o n dl y, ris ks of a d v erse effects are li kel y t o be n ota bl y l o w as 
o ur ne w a ge nt is f o o d- base d wit h 4 4 % v/ v air i n water, 2 % e g g w hite pr ot ei n, less t h a n 
1 % b uffer a ge nt, a n d less t ha n 1 % f oa m sta bilizer a n d taste i m pr o vi n g a d diti v es. 
 
 

S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
4 4 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
1 5  D A T A M A N A G E M E N T A N D Q U A L I T Y A S S U R A N C E 
1 5. 1  Q u alit y Ass ur a nce 
T he S p o ns or or desi g n ee will c o n d uct a sit e visit t o verif y t he q ualificati o ns of t he 
I n v esti gat or, i ns pect t h e site facilities, a n d i nf or m t he I n vesti gat or of res p o nsi bilities a n d 
t he pr oce d ures f or e ns uri n g a de q uate a n d c orrect d oc u me ntati o n. 
T he I n vesti g at or is re q uire d t o pre pare a n d m ai ntai n a de q uat e a n d acc urate case hist ories 
desi g ne d t o rec or d all o bser vati o ns a n d ot her data p erti ne nt t o t he trial f or e ac h trial 
partici pa nt. All i nf or mati o n rec or de d o n t h e C R Fs f or t his trial m ust, if a p pli ca ble, be 
c o nsiste nt wit h t he s u bjects’ s o urce d o c u me ntati o n (i. e., me dical rec or ds). 
Trial sit es, facilities, la b orat ories a n d all data (i ncl u di n g s o urces) a n d d o c u me ntati o n 
m ust b e a vaila bl e f or G C P a u dit b y L u me nt A B or i ns pecti o n b y c o m pet e nt a ut h oriti es. 
A n y as pect of t he trial ma y b e s u bject t o a u dit b y L u me nt A B a n d/ or i ns p ecti o n b y 
re g ul at or y a ut h orities or I E C. S uc h a u dits/i ns pecti o ns ma y ta ke place at t h e s p o ns or’s 
site(s) or at a n y trial site i ncl u di n g la b orat ories, p har macies etc. 
T he m o nit or will, i n case of a u dit, a n n o u nce t his i n a d va nce t o t he i n vesti gat or a n d b e 
prese nt at t h e p artic ular trial site d uri n g t he a u dit. 
T he sit e staff s h o ul d assist i n all as pects of a u dit/i ns pecti o n. 
1 5. 2  Tri al M o nit ori n g 
L u me nt A B, as s p o ns or of t his cli nical trial, is res p o nsi ble t o t he re g ulat or y a ut h orities f or 
ass uri n g t he pr o per c o n d uct of t h e cli nical trial wit h re g ar d t o pr ot oc ol a d here nce a n d 
vali dit y of t he data rec or de d i n t he C R Fs. T he c o m pa n y has t h eref ore assi g ne d a C R O t o 
m o nit or t his trial. T heir d uties are t o ser v e as t he pri nci pal li n k bet wee n i n v esti gat ors a n d 
L u me nt A B a n d a d vise t he i n vesti gat or o n t h e c ollecti o n a n d mai nte na nce of attri b uta bl e, 
le gi ble, c o nte m p ora n e o us, ori gi n al a n d acc urate d ata f or t he tri al. I n a d diti o n, t he y will 
e x plai n t o t h e i n vesti gat ors a n y as p ect of t h e (c o n d uct of t he) trial, i n cl u di n g 
i nter pretati o n of t h e pr ot oc ol, t h e p ur p ose of c ollecti n g t h e s pecifie d data a n d re p orti n g 
res p o nsi bilities. 
T he m o nit or will visit t h e tri al sit es bef ore, d uri n g a n d after t h e trial t o e ns ure t hat t he 
trial is c o n d ucte d a n d d o c u me nte d i n acc or da nce wit h t his pr ot oc ol, I C H G C P g ui deli nes, 
re g ul at or y r e q uire me nts, a n d a n y trial s pecific d oc u me nts s u c h as C R F c o m pleti o n 
g ui deli nes. 
M o nit ori n g visits will be c o n d ucte d t o c o nfir m t hat e. g.: 
 T he ri g hts a n d well- b ei n g of h u ma n s u bjects are pr ot ect e d 

S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
4 5 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
 T he i n vesti gati o nal tea m is a d heri n g t o t h e trial pr ot oc ol 
 I nf or me d c o ns e nt has bee n o btai n e d fr o m all partici pa nts 
 A Es ha ve b ee n re p orte d as re q uire d 
 Data are bei n g acc uratel y rec or de d i n t he C R Fs a n d are i n acc or d a nce wit h 
s o urce data 
 I P is bei n g st ore d c orrectl y a n d dr u g acc o u nta bilit y is bei n g perf or me d o n a n 
o n- g oi n g basis 
 I P is gi v e n t o c orrect s u bject 
 Facilities ar e, a n d re mai n, acc e pta bl e t hr o u g h o ut t he trial 
 T he I n vesti g at or a n d t he site are recei vi n g s ufficie nt i nf or mati o n a n d s u p p ort 
t hr o u g h o ut t h e trial 
T he C R F data will be m o nit ore d o n at re g ular i nter vals. T h e m o nit ori n g will i n cl u de 
s o urce data v erifi cati o n ( S D V) acc or di n g t o t he S D V list a n d verifi cati o n of data 
c o nsiste nc y o ver ti me. T he I n vesti g at or a n d ot her rele va nt trial p ers o n n el s h o ul d be 
a vaila bl e d uri n g t h e m o nit ori n g visits. 
I n or der t o perf or m t heir r ole effecti vel y, m o nit ors a n d pers o ns i n v ol ve d i n q ualit y 
ass ura n ce a n d i ns p ecti o ns (see a b o v e) will nee d direct access t o pri mar y s u bject data, 
e. g., me di cal rec or ds, a p p oi nt me nt b o o ks, etc. T he re vie w of me dical rec or ds will b e 
perf or me d i n a ma n n er t o e ns ure t h at s u bj ect c o nfi d e ntialit y is mai ntai ne d. Beca use t his 
affects t he s u bject’s c o nfi de ntialit y, t his fact is i n cl u de d o n t he S u bj ect I nf or mati o n S h eet 
a n d I nf or me d C o nse nt F or m. T he I n v esti g at or ass ures t h e S p o ns or of t h e n ecessar y 
s u p p ort at all ti mes. 
T his trial is or ga nise d b y L u me nt A B, a n d all e n q uiries s h o ul d be ma de t o a me m ber of 
L u me nt A B staff (se e S ecti o n 2 ). 
1 5. 3  C o nfi de nti alit y 
All trial fi n di n gs a n d d oc u me nts will be re gar d e d as c o nfi de ntial. T h e I n vesti gat or a n d 
me m bers of his/ her researc h t ea m m ust n ot dis cl ose s u c h i nf or m ati o n wit h o ut pri or 
writte n a p pr o val fr o m t he S p o ns or. 
T he a n o n y mit y of partici pati n g s u bjects m ust b e mai nt ai ne d. S u bjects will be i d e ntifie d 
o n C R Fs b y t h eir s u bject n u m ber. O n t he S A E re p orts a n d all ot her s o urce d oc u me nts, 
t he s u bject will be i d e ntifie d via s u bj ect n u m b er. D oc u me nts ar e n ot t o be s u b mitt e d t o 
t he S p o ns or t h at i d e ntif y t he s u bj ect (e. g., t h e si g n e d i nf or me d c o ns e nt) m ust be 
mai ntai n e d i n c o nfi d e nce b y t h e I n v esti g at or.  

S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
4 6 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
1 5. 4  S o urce D at a 
S o urce d at a : All i nf or mati o n i n ori gi n al rec or ds a n d certifi e d c o pies of ori gi n al rec or ds 
of cli nical fi n di n gs, o bs er vati o ns, or ot her acti vities i n a cli nical trial necessar y f or t he 
rec o nstr ucti o n a n d e val u ati o n of t h e tri al. S o urce data are c o nt ai ne d i n s o urce d oc u m e nts 
( ori gi n al rec or ds or certifie d c o pi es) (I C H E 6, 1. 5 1). 
S o urce d oc u me nts : Ori gi n al d oc u me nts, d ata, a n d rec or ds (e. g., h os pital rec or ds, cli nical 
a n d office c h arts,  me m ora n d a, s u bje cts diaries or e val uati o n c h ec klists, p har mac y 
dis p e nsi n g rec or ds, rec or de d dat a fr o m a ut o mate d i nstr u me nts, c o pies or tra nscri pti o ns 
certifi e d aft er v erific ati o n as b ei n g acc urat e c o pies, micr ofic hes, p h ot o gra p hic n e gati ves, 
micr ofil m or ma g netic m e dia, x-ra ys, s u bject files, a n d rec or ds ke pt at t he p har mac y, at 
t he la b orat ories a n d at m e dic o-tec h ni cal de p art m e nts i n v ol ve d i n t he cli ni cal trial). (I C H 
E 6, 1. 5 2). 
S D V is a ke y f u n cti o n i n ass uri n g t he s p o ns or t hat cli nical trial i nf or mati o n is rec or de d 
a n d ha n dl e d i n a w a y t h at all o ws its acc urate re p orti n g, i nter pretati o n a n d v erificati o n. 
M o nit ors will, d uri n g t he c o n d u ct of t he cli nical trial, perf or m S D V t o c o nfir m t he 
acc urac y a n d c o m pl ete ness of C R Fs b y verif yi n g dat a rec or de d i n t he C R F a gai nst d ata 
rec or d e d i n s o urce d oc u me nts t o e ns ure s u c h rec or ds are c o nsiste nt.  
T o e na bl e S D V, it is esse ntial t h at s o urce data/ d oc u me nts (see defi niti o n a b o v e) f or t he 
trial data t o b e c ollecte d i n t h e C R F as w ell as w h ere s u c h data ca n b e f o u n d at t he trial 
site is esta blis he d a n d a gree d wit h t h e i n v esti g at or at eac h trial site a n d d oc u me nte d, pri or 
t o i nitiati o n of t h e cli nical trial. T he C R F is esse ntiall y c o nsi dere d a data e ntr y f or m a n d 
s h o ul d n ot c o nstit ute t he ori gi n al ( or s o urce) me di cal rec or ds u nless ot her wise s pecifie d 
i n t he Ori gi n of s o urce d ata d oc u me nt at site. 
F or t his trial, si nce data are e ntere d i nt o C R F, all p ara met ers c ollecte d i n t h e C R F s h o ul d 
be v erifia bl e fr o m s o ur ce d oc u me nts a vaila ble o n site. T h ese para meters i n cl u d e, b ut are 
n ot li mite d t o: 
 A st at e me nt t hat t h e s u bj ect partici p at es i n a cli ni cal trial 
 T he i d e ntit y of t he trial e. g., Trial c o de 
 S u bject / n u m b er 
 date of c o n d u cti n g i nf or me d c o nse nt pr ocess 
 data f or e val uati o n of eli gi bilit y criteria 
 dis p e nsati o n/a d mi nistrati o n of tri al me di cati o n 
T he I n vesti g at or is res p o nsi ble f or e ns uri n g t h e acc urac y, c o m pl et e n ess, le gi bilit y a n d 
ti meli ness of t he data rec or de d i n t he C R Fs. Data re p ort e d i n t h e C R F t hat are deri ve d 
fr o m s o urce d o c u me nts s h o ul d be c o nsiste nt wit h t he s o urce d oc u me nts or t he 

S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
4 7 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
discre pa n cies s h o ul d b e e x plai ne d. C o m plete d secti o ns of C R Fs will be m o nit ore d o n a 
re g ul ar b asis. 
1 5. 5  C ase Re p o rt F or ms ( C R Fs) 
Data c ollecte d i n t his trial will be b y mea ns of p a per C R Fs.  
T he C R Fs m ust be mai ntai ne d i n a n u p-t o- date c o n diti o n at all ti mes b y t he i n vesti gat or. 
T he i n vesti gat or, or s u b-i n vesti gat or(s) a ut h orise d b y t h e i n vesti gat or, will si g n all 
secti o ns of C R Fs use d. T his si g nat ure i nf or mati o n (i ncl. date of si g nat ure) will be ke pt i n 
t he a u dit trail a n d is u naltera bl e. O nl y a p pr o priat el y me dicall y q ualifie d 
(s u b)i n vesti g at ors ca n si g n dat a o n cli ni cal ass ess m e nts/safet y. A n y c orrecti o n(s) ma de 
b y t h e i n vesti gat or, or a ut h oris e d sit e staff, t o t h e C R F after ori gi nal e ntr y will be 
d oc u me nt e d i n t he a u dit trail. C h a n ges t o data alrea d y a p pr o ve d, re q uires t he re-si g nat ure 
of i n vesti gat or or a ut h orise d staff. T he a u dit trail will i de ntif y t he pers o n ma ki n g t he 
c ha n ge a n d t he d ate, ti me a n d reas o n f or t he c ha n g e.  
T he trial m o nit or will c hec k t he C R Fs f or acc urac y a n d c o m pl eti o n a n d p erf or m s o urce 
data verificati o n. F or arc hi vi n g p ur p os es, eac h i n vesti gat or will be s u p plie d wit h a c o p y 
of t h e C R Fs, f or all pati e nts e nr oll e d at t h e site. A u dit trail i nf or mati o n will be i n cl u de d. 
C R Fs will be a vaila ble f or i ns pecti o n b y a ut h orise d re pres e nt ati ves fr o m L u me nt A B, 
fr o m Re g ulat or y A ut h orities a n d/ or I E C. 
1 5. 6  D at a M a n a g e me nt 
P atie nt dat a s h o ul d b e e nt ere d i nt o t he C R F b y a ut h orise d site st aff i n a ti m el y ma n ner 
a n d n ot l ater t ha n a wee k after t he p atie nts’ visits. Data will be e ntere d o n t he p a per C R F 
b y site st aff  
W he n a p a per C R F is c o m pl ete d a n d si g ne d b y sit e staff it will b e se nt t o Stat C o ns f or 
data e ntr y. P ers o n n el at St at C o ns will e nter t he data i nt o a n electr o ni c data b ase. T he d ata 
e ntr y will b e v erifie d b y pr o ofrea di n g b y p ers o n nel at Stat C o ns. W he n all dat a fr o m all 
pa per C R Fs are e nt ere d i nt o t he el ectr o nic d ata base a n d pr o ofrea d t h e d ata base will b e 
l oc ke d a n d se n d t o t he s p o ns or f or arc hi vi n g. As well t he statisti cal a nal ys es/s u m maries 
will start base d o n data i n t h e l o c ke d data b ase. 
A n y de viati o ns, i.e., discre pa ncies a n d a d diti o ns fr o m t he pr ocess d efi n e d i n t h e Data 
Ma na ge me nt Pl a n, will be descri b e d i n t h e statistical re p ort. 
1 5. 7  Arc hi vi n g Tri al Rec or ds 
Acc or di n g t o I nter nati o n al C o nfere n ce o n H ar m o nisati o n (I C H) g ui deli nes, esse nti al 
d oc u me nts s h o ul d be retai n e d f or a mi ni m u m of 2 years after t he l ast a p pr o val of a 
mar keti n g a p plicati o n i n a n I C H re gi o n a n d u ntil t here are n o p e n di n g or c o nte m plate d 

S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
4 8 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
mar keti n g a p plicati o ns i n a n I C H re gi o n or at least 2 y ears ha ve ela ps e d si nce t he f or mal 
disc o nti n u ati o n of cli nical de vel o p me nt of t he i n v esti gati o nal pr o d uct. H o w e ver, t hes e 
d oc u me nts s h o ul d be retai n e d f or a l o n ger peri o d if re q uire d b y t h e a p pli ca ble l e gal 
re q uire me nts. 
 
 

S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
4 9 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
1 6  T R I A L M A N A G E M E N T  
1 6. 1  Ti me Sc he d ule 
 Pla n n e d date of e nr ol me nt of first patie nt: Ja n uar y 2 0 2 3. 
 Pla n n e d date of e nr ol me nt of l ast patie nt: Fe br uar y 2 0 2 3. 
1 6. 2  Pr ot oc ol A me n d me nts 
Neit h er t he i n v esti g at or(s) n or L u me nt A B will c ha n g e t h e Cli ni cal St u d y Pr ot o c ol 
wit h o ut writte n a gree m e nt bet wee n L u me nt A B a n d t h e I n vesti gat or. A n y m o dificati o n 
c o nsi d ere d s u bsta ntial re q uires a p pr o v al/fa v o ura ble o pi ni o n b y t he a p pr o priate re g ulat or y 
a ut h orit y a n d I E C/I R B. 
N o n-s u bsta ntial c ha n ges (e. g., C h a n ges n ot affecti n g t h e s u bj ect b e nefit/ris k rati o) ma y 
be ma de wit h o ut t he ne e d f or a f or mal I E C/ C o m p ete nt A ut h orit y a p pr o val. All n o n-
s u bst a nti al a me n d me nts will b e l o g ge d o n a n o n-s u bsta ntial a me n d me nt list. All n o n-
s u bst a nti al a me n d me nts will b e distri b ute d t o all pr ot oc ol reci pie nts, wit h a p pr o priate 
i nstr ucti o ns. 
Pr ot oc ol a me n d me nts are iss ue d as C o ns oli date d Cli nical St u d y Pr ot oc ols c o m prisi n g all 
c urre nt a me n d me nts. C o ns oli date d Cli nical St u d y Pr ot oc ols bec o me effecti ve w he n 
writte n a p pr o val h as bee n pr o vi d e d b y t he I n v esti g at or, t he S p o ns or, a n d 
a p pr o v al/fa v o ura ble o pi ni o n fr o m re g ul at or y a ut h oriti es a n d/ or I E C has bee n o btai n e d, as 
re q uire d. 
1 6. 3  A gree me nts 
Bef ore t he i nitiati o n of a cli nical trial at a trial site, all fi n a ncial arra n g e me nts wit h t he 
i n v esti g at or/i nstit uti o n a n d all ot her rele v a nt parti es (s uc h as la b orat ories) m ust be 
c o nfir me d i n writi n g i n f or mal a gree me nt(s). 
1 6. 4  D ur ati o n of t he Tri al 
T he d urati o n of t he tri al f or eac h s u bj ect fr o m scree ni n g t o t h e F oll o w- u p ( or earl y 
ter mi n ati o n) visit will be u p t o 1 7 da ys, d e pe n di n g o n t he a vaila ble ti me sl ots f or M R E 
e xa mi nati o n.  
T he trial will be cl os e d w h e n all e nr olle d s u bje cts ha ve c o m plete d t h e last s u bject l ast 
visit, as d efi n e d i n secti o n 8. 4 Defi niti o n of E n d of St u d y. 
1 6. 5  C o m pleti o n of Tri al 
1 6. 5. 1  Tri al C o m pl eti o n Pr oce d ures 
T he e n d of trial is defi ne d as t he d ate of t h e last s u bject l ast visit. 

S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
5 0 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
T he I n vesti g at or will be i nf or me d w he n s u bj ect recr uit m e nt is t o cease. 
Trial e nr ol me nt will be st o p pe d w he n t he t ot al re q ueste d n u m b er of e val ua ble s u bjects f or 
t he tri al has b ee n o bt ai ne d i.e., 1 0 s u bjects. 
U p o n c o m pleti o n of t he tri al, L u me nt A B will u n derta ke arra n ge me nts f or c ollecti o n a n d 
dis p osal of a n y u n use d tri al material t hat t he i n vesti gat or is n ot re q uire d t o k ee p i n his/ her 
fil es. 
T he trial ma y st o p pre mat urel y if t h e I n v esti gat or or t h e S p o ns or bec o mes a ware of 
c o n diti o ns or e ve nts t h at s u g gest a p ossi ble h azar d t o s u bjects if t h e trial c o nti n ues. I n t his 
case, t he tri al ma y be ter mi n ate d after a p pr o priate c o ns ult ati o n bet wee n t he rele va nt 
parties. T h e trial ma y als o be ter mi nate d earl y at t he S p o ns or’s discreti o n i n t he a bse nce 
of s uc h a fi n di n g. 
C o n diti o ns t h at ma y warra nt ter mi nati o n i n cl u de, b ut are n ot li mit e d t o: 
 T he disc o ver y of a n u ne x pecte d, si g nifica nt, or u n acce pt a ble ris k t o t he s u bjects 
e nr olle d i n t h e trial. 
 Fail ure t o e nr ol s u bj ects at a n acce pta ble rate. 
 A d ecisi o n o n t he part of t h e S p o ns or t o s us pe n d or disc o nti n u e de vel o p me nt of 
L u me nti n  4 4. 
1 6. 6  Li a bilit y a n d I ns ur a nce 
L u me nt A B will ta ke o ut reas o na bl e t hir d- part y li a bilit y i ns ura n ce c o v er i n acc or da nce 
wit h all l ocal l e gal re q uire me nts. T he ci vil li a bilit y of t he I n vesti gat or, t he pers o ns 
i nstr ucte d b y hi m/ h er a n d t he h os pital, practi ce or i nstit ute i n w hi c h t he y are e m pl o ye d 
a n d t he lia bilit y of t h e S p o ns or wit h res p ect t o fi na n ci al l oss d ue t o pers o nal i nj ur y a n d 
ot h er d a ma ge t h at ma y arise as a res ult of t h e carr yi n g o ut of t his tri al are g o ver ne d b y t he 
a p pli ca ble l a w. 
L u me nt A B will arra n ge f or Lia bilit y I ns ura nce if s u bjects s h o ul d b e i nj ure d d u e t o t he 
partici pati o n i n t h e trial a n d pr o vi d e d t h at s p o ns or is le gall y lia ble f or t hat. 
E xcl u de d fr o m t he i ns ura nce c o v er are i nj uries t o healt h a n d deteri orati o ns of ill nesses 
alrea d y i n e xiste nce w hi c h w o ul d ha ve occ urre d or c o nti n ue d t o e xist e ve n if t he s u bject 
ha d n ot t a ke n p art i n t he cli nical tri al. 
T he i ns ura nce c o ver is j e o par dis e d if t he s u bj ect fails t o re p ort i m m e diatel y t o t h e 
I n v esti gat or or res p o nsi ble p h ysicia n a n y i nj ur y t o healt h, w hic h mi g ht ha ve res ulte d 
fr o m partici pati o n i n t he cli ni cal trial, or if he/s he u n d er g oes a n y ot h er me dical treat me nt 

S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
5 1 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
wit h o ut t heir c o nse nt bef ore t he cli ni cal tri al h as bee n fi nis he d i ns ofar as t h e i n di vi d ual 
s u bj ect is c o ncer n e d. 
A n y i nj ur y t o h ealt h, w hic h mi g ht h a ve occ urre d as a res ult of partici pati o n i n t he cli ni cal 
trial, m ust be re p orte d b y t he s u bject t o t h e I n vesti gat or wit h o ut d ela y. T he I n v esti gat or is 
o bli g e d t o ma k e s u c h a re p ort i n a n y cas e. 
1 6. 7  Use of i nf or m ati o n 
All u n p u blis he d i nf or m ati o n relati n g t o t his cli nical trial a n d/ or t o t he i n v esti g ati o nal 
pr o d uct(s), is c o nsi dere d c o nfi de ntial b y L u me nt A B a n d s h all re mai n t h e s ol e pr o pert y 
of L u m e nt A B. T he i n vesti g at or s h o ul d u n dersta n d a n d a gree t h at L u me nt A B ma y use 
t he i nf or mati o n fr o m t his cli ni cal trial i n c o n n ecti o n wit h t he de vel o p m e nt of t h e pr o d uct, 
a n d t heref ore, ma y dis cl ose it as re q uire d t o ot her i n vesti gat ors, t o re g ulat or y a ut h orities 
a n d c o m mercial part n ers. 
1 6. 8  P u blic ati o n P olic y 
B y si g ni n g t he trial pr ot oc ol, t h e I n vesti gat or a grees wit h t he use of res ults of t he tri al f or 
t he p ur p oses of n ati o nal a n d i nter n ati o nal re gistrati o n, p u blicati o n a n d i nf or mati o n f or 
me di cal a n d p har mace utical pr ofessi o nals. If necessar y, t h e a ut h orities will be n otifie d of 
t he I n v esti g at or's na me, a d dress, q u alificati o ns a n d e xte nt of i n v ol ve me nt. 
A n i nte grate d cli nic al trial re p ort will b e pre pare d b y t he S p o ns or a n d re vie we d b y 
I n v esti gat or. A s u m mar y of t h e cli nical trial re p ort (acc or di n g t o C P M P/I C H 1 3 7/ 9 5) 
s h o ul d be se nt t o t he R e g ulat or y A ut h orities a n d I E C acc or di n g t o t h e rele v a nt g ui deli nes. 
N o data fr o m t h e cli nical trial ma y b e p u blis he d, prese nte d or c o m m u ni cate d, e xce pt t o 
re g ul at or y a ut h orities, pri or t o t h e release of t he i nt er nal cli nical tri al re p ort, u nless 
a p pr o v e d b y t he S p o ns or i n writi n g. 
I n t he e ve nt of a p u bli cati o n, t h e na mes of t he a ut h ors a n d t heir or der of a p peara n ce will 
be i n acc or da nce wit h t he a gree m e nt i nt er peers, vi z. pa pers m ai nl y deali n g wit h me dical 
a n d gastr oe nter ol o gical d ata will prese nt t h e n a me of t he pri nci pal gastr oe nter ol o gist first 
( or l ast if wis h e d f or). Pa pers mai nl y deali n g wit h ra di ol o gi c iss ues will prese nt t he na me 
of t h e pri nci pal ra di ol o gist first ( or l ast if wis he d f or). T he sec o n d n a me will b e t h e 
pri nci pal a ut h or of t he ot her s p ecialit y. All ot her a ut h ors will pri maril y be prese nte d i n 
al p ha betic or d er. 
 
 

S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
5 2 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
1 7  R E F E R E N C E L I S T 
Lea n der P, A d ner hill I, B ö ö k O, Casal- D ujat L, Stat his G, F or k T. A n o v el f o o d- bas e d 
f oa m as oral c o ntrast a g e nt wit h n e gati ve H o u nsfiel d u nits f or de marcati o n of s mall 
b o wel l o o ps o n a b d o mi nal C T: t olera bilit y a n d b o wel diste nsi o n i n 2 5 v ol u nteers. Acta 
Ra di ol. 2 0 2 1 Dec; 6 2( 1 2): 1 5 5 9- 1 5 6 6.  
Lea n der P, St at his G, Casal- D ujat L, B o ma n K, A d ner hill I, M arsal J, B ö ö k O, F or k T. A 
n o vel f o o d- bas e d ne g ati v e oral c o ntrast a ge nt c o m pare d wit h t w o c o n ve nti o n al oral 
c o ntrast a ge nts i n a b d o mi nal C T: a t hree-ar m parallel bli n d e d ra n d o mise d c o ntr olle d 
si n gle-ce ntre trial. E ur R a di ol E x p. 2 0 2 2 A pr 5; 6( 1): 1 5.  
 
 

S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
5 3 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
1 8  A P P E N D I C E S  
1 8. 1  A p pe n di x 1: L u me nti n 4 4 rec o nstit uti o n pr ot oc ol s u m m ar y  
S U M M A R Y O F C M P D U O P E R A TI O N 
Gl o ves o n 
I. F or t he pre p arati o n f or o ne trial s u bject, gat h er t w o L 4 4 p o w der s ac hets, t w o glass j ars, 
t w o 1. 5- L P E T j ars a n d t w o 0. 5- L b ottles of wat er. 
P R E P A R A TI O N O F T H E FI R S T F O A M 
2. Fill i n t h e B E F O R E F O A M P R E P A R A TI O N s ecti o n o n t he W hi p pi n g 
re p ort _ L U M RI S- 0 0 1 V 3. 0. 
3. O pe n o ne L 4 4 p o w d er sac het a n d p o ur t he e ntir e sac het of p o w der i nt o o ne of t he gl ass 
jars o utsi d e t h e mi xi n g c ha m ber of t he C M P D U. 
4. Ma ke s ure t he C M P D U is s u p plie d wit h electricit y a n d t ur n o n p o wer ( b utt o n o n t he 
bac k si de). 
5. O pe n t h e mi xi n g c ha m ber d o or. 
6. I nstall t h e mi xi n g t o ol. 
7. P ut t h e jar i nt o t h e mi xi n g c ha m ber. 
8. C L O S E t he mi xi n g c ha m b er d o or. 
9. O pe n t h e wat er b ottl e. 
1 0. C o n nect w at er b ottle t o t he C M P D U. 
1 1. Ma ke s ure t h e water b ottl e is ti g hte ne d e n o u g h t o t h e c o n nect or a n d t h e b ottle is 
place d at t h e l o w er p ositi o n, s o water sta ys i n t he b ottle. 
1 2. Press t he start b utt o n. 
1 3. Fli p t h e b ottle t o t h e t o p p ositi o n. 
1 4. Wait u ntil t h e L 4 4 f oa m rec o nstit uti o n is fi nis h e d, w hic h is i n dicate d b y t he c o m plete 
li g hte ne d L E D li g hts o n t he H MI. 
1 5. Fli p d o w n t he wat er b ottle. 
1 6. O pe n t he mi xi n g c ha m ber d o or. 
1 7. Ta ke o ut t he mi xi n g t o ol wit h a pi ece of kitc he n pa per t o wel u n d er neat h t o c o ntai n 
t he e xcess f oa m fr o m t he bla de; was h t he mi xi n g t o ol a n d dr y it wit h kitc he n pa per t o wel. 
I nstall bac k t he mi xi n g t o ol t o t he C M P D U. 

S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
5 4 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
1 8. Ta ke o ut t he jar fr o m t h e mi xi n g c ha m ber a n d cl ose t h e d o or of t he mi xi n g c ha m ber. 
1 9. Fill i n t he A F T E R F O A M P R E P A R A TI O N secti o n o n t h e W hi p pi n g 
re p ort _ L U M RI S- 0 0 1 _ V 3. 0. 
2 0. G E N T L Y p o ur o ut L 4 4 t o a 1. 5- L P E T jar. 
2 1. Ta ke t he 1. 5- L P E T j ar wit h L 4 4 f oa m a n d wal k t o war ds w here t he trial s u bject is 
sitti n g. 
2 2. Gi v e t h e trial s u bject t h e L 4 4 f oa m i n t he 1. 5- L P E T j ar a n d a s mall dri n ki n g c u p. 
2 3. G o bac k t o pre pare t h e sec o n d jar of L 4 4 acc or di n gl y. 
P R E P A R A TI O N O F T H E S E C O N D F O A M 
2 4. Fill i n t he B E F O R E F O A M P R E P A R A TI O N secti o n o n t h e W hi p pi n g 
re p ort _ L U M RI S- 0 0 1 V 3. 0. 
2 5. O pe n o ne L 4 4 p o w der sac het a n d p o ur t he e ntire sac h et of p o w d er i nt o o ne glass jar 
o utsi de t h e mi xi n g c ha m ber of t h e C M P D U. 
2 6. Ma ke s ure t h e p o wer is o n. 
2 7. O pe n t he mi xi n g c ha m ber d o or. 
2 8. I nstall t h e mi xi n g t o ol. 
2 9. P ut t h e jar i nt o t he mi xi n g c ha m ber. 
3 0. C L O S E t he mi xi n g c ha m ber d o or. 
3 1. O pe n a ne w b ottl e of water b ottl e. 
3 2. Re place t h e e m pt y b ottl e of water wit h t h e n e w b ottle; c o n nect t he ne w wat er b ottle 
t o C M P D U. 
3 3. Ma ke s ure t h e water b ottl e is ti g hte ne d e n o u g h t o t h e c o n nect or a n d t h e b ottle is 
place d at t h e l o w er p ositi o n, s o t he water sta ys i n t he b ottle. 
3 4. Press t he start b utt o n. 
3 5. Fli p t h e b ottle t o t h e t o p p ositi o n. 
3 6. Wait u ntil L 4 4 f oa m rec o nstit uti o n is fi nis he d, w hic h is i n dicate d b y t he c o m plete 
li g hte ne d L E D li g hts o n t he H MI. 
3 7. Fli p d o w n t he wat er b ottle. 
3 8. O pe n t he mi xi n g c ha m ber d o or. 

S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
5 5 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
3 9. Ta ke o ut t he mi xi n g t o ol wit h a pi ece of kitc he n pa per t o wel u n d er neat h t o c o ntai n 
t he e xcess f oa m fr o m t he bla de; was h t he mi xi n g t o ol q uic k y wit h ta p water a n d dr y it 
wit h kitc he n pa per t o w el. I nstall bac k t he mi xi n g t o ol t o t he C M P D U. 
4 0. Ta ke o ut t he jar fr o m t h e mi xi n g c ha m ber a n d cl ose t h e d o or of t he mi xi n g c ha m ber. 
4 1. Fill i n t he A F T E R F O A M P R E P A R A TI O N secti o n o n t h e W hi p pi n g 
re p ort _ L U M RI S- 0 0 1 _ V 3. 0. 
4 2. G E N T L Y p o ur o ut L 4 4 f oa m t o t h e 1. 5- L P E T j ar. 
4 3. Ta ke t he 1. 5- L P E T j ar wit h L 4 4 f oa m a n d wal k t o war ds w here t he trial s u bject is 
sitti n g. 
4 4. Gi v e t h e trial s u bject t he L 4 4 f oa m i n t he 1. 5- L P E T j ar a n d a s mall dri n ki n g c u p. 
4 5. G o bac k t o t h e C M P D U. 
4 6. Disc o n n ect t he e m pt y water b ottl e if t his is t he last f oa m t o pre pare of t h e da y; 
ot h er wise, l ea v e t h e b ottle c o n necte d bef ore ma ki n g a ne w f o a m wit h a ne w b ottle of 
water. 
4 7. Rec ycl e t h e w ater t u bi n g set bac k t o L u me nt A B after t h e last f oa m of t he da y. 
4 8. After t he last f oa m of t he d a y, ha n d w as h t he mi xi n g t o ol wit h f o o d- gra de deter ge nt 
a n d dr y wit h kitc he n tiss ue t o wel or w as h t h e mi xi n g t o ol i n t he dis h was her (f o o dst uff 
c o m p ati ble is s ufficie nt). 
4 9. Wi pe t he mi xi n g c ha m ber if a n y visi ble L 4 4 h as dr o p p e d. 
5 0. P o wer off t he C M P D U at t h e e n d of t he d a y ( b utt o n o n t he bac k si de of t h e C M P D U). 
5 1. If t here is a n y f oa m dr o p pe d o nt o t he jar h ol der, press t h e cl ea ni n g m o d e b utt o n t o let 
l o ose t h e jar h ol der. 
5 2. Ha n d was h or was h i n t h e dis h was her t he jar h ol d er. 
5 3. Fi x t h e jar h ol der b ac k i nt o t he mi xi n g c ha m ber o n ce it's clea ne d. 
 
 
 

S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
5 6 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
1 9  S I G N A T U R E P A G E S 
 
Decl ar ati o n of S p o ns o r o r Res p o nsi ble Me di c al Officer 
Title: A n u nc o ntr olle d, si n gle ce ntre, healt h y v ol u nteer, P hase II pr o of- of-c o n ce pt trial 
i n v esti g ati n g M R-e nter o gra p h y i ma ge q u alit y of L u m e nti n®  4 4, a ne w e g g al b u me n 
base d oral s mall b o wel filli n g c o ntrast a ge nt. 
T his trial pr ot o c ol was s u bject e d t o criti cal re vi e w. T he i nf or mati o n it c o ntai ns is 
c o nsiste nt wit h c urre nt k n o wle d g e of t h e ris ks a n d be nefits of t h e i n vesti gati o nal pr o d uct, 
as well as wit h t he m oral, et hical a n d scie ntific pri n ci ples g o ver ni n g cli nical researc h as 
set o ut i n t he Decl ar ati o n of Helsi n ki, re vise d 2 0 1 3, a n d t he g ui d eli n es o n G o o d Cli nical 
Practice ( G C P). 
 
 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 
Ja n Marsal, M D, P h D 
Date 
  
De part me nt of Gastr oe nt er ol o g y 
S ka ne U ni v ersit y H os pital 
S U S L u n d E A 1 2 
S E- 2 2 1 8 5 L u n d 
S we de n 
P h o n e: + 4 6 4 6 1 7 7 0 0 3 
M o bile p h o ne: + 4 6 7 0 9 8 2 2 0 0 8 
E- mail: j a n. marsal @ me d.l u.se 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 
J o ha n Q u e nsel, C E O 
Date 
Q Cli nical R esearc h C o ns ulti n g A B 
Lärar v ä ge n 1 2 
S E- 2 4 7 4 5 T or na Hällest a d 
S we de n 
P h o n e: + 4 6 7 6 0 4 6 9 7 4 4 
E- Mail: j q @ qcrc.se  

S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
5 7 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
Decl ar ati o n of t he I n vesti g at or 
Title:  A n u nc o ntr olle d, si n gle ce ntre, healt h y v ol u nteer, P hase II pr o of- of- c o nce pt trial 
i n v esti g ati n g M R-e nter o gra p h y i ma ge q u alit y of L u m e nti n®  4 4, a ne w e g g al b u me n 
base d oral s mall b o wel filli n g c o ntrast a ge nt. 
T his trial pr ot o c ol was s u bject e d t o criti cal re vi e w. T he i nf or mati o n it c o ntai ns is 
c o nsiste nt wit h c urre nt k n o wle d g e of t h e ris ks a n d be nefits of t h e i n vesti gati o nal pr o d uct, 
as well as wit h t he m oral, et hical a n d scie ntific pri n ci ples g o ver ni n g cli nical researc h as 
set o ut i n t he Decl ar ati o n of Helsi n ki, re vise d 2 0 1 3, a n d t he g ui d eli n es o n G o o d Cli nical 
Practice ( G C P). 
 
 
 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 
Si g nat ure  
  
  
  
  
  
Date 
 
Dr. Peter Lea n der 
R ö nt ge n, Perit us kli ni k e n A B 
S c heele vä g e n 8 
2 2 3 6 3 L u n d 
S we de n 
 
P h o n e: + 4 6 4 6 2 8 8 6 0 3 0 
M o bile p h o ne: + 4 6 7 6 8 8 7 1 0 6 9 
E- Mail: peter.lea n der @ perit us kli ni ke n.se