Oral CDX-7108 in Healthy Adults and EPI Subjects
Condition: Exocrine Pancreatic Insufficiency
MeSH terms: Exocrine Pancreatic Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase 1a/1b single and multiple ascending dose study of oral CDX-7108 in healthy adult
      subjects and a single dose proof-of-concept study of oral CDX-7108 in subjects with exocrine
      pancreatic insufficiency.

      No clinical studies have yet been performed with CDX-7108 and its effects in humans are
      unknown. This is the first-in-human (FIH) study of CDX-7108, which aims to assess the safety,
      tolerability, pharmacokinetics (PK) of escalating single and multiple oral doses of CDX-7108
      in healthy adult subjects and to evaluate the pharmacodynamics of a single dose of oral
      CDX-7108 in a proof-of-concept (POC) study in subjects with exocrine pancreatic insufficiency
      (EPI).
    

Detailed description: 
      This is an integrated 3-part study to investigate the safety, tolerability, PK, and PD of
      CDX-7108. The Parts A and B are randomized, double-blind, placebo-controlled dose escalation
      parts to investigate the safety, tolerability, immunogenicity, and PK of CDX-7108 after
      single and multiple oral dose administration in healthy adult subjects. Part C is a
      randomized, double-blind, placebo-controlled, single-dose, 2-way crossover part to assess POC
      of CDX-7108 in terms of PD as well as its safety, tolerability, and immunogenicity in
      subjects with EPI. The study will commence with Part A (single ascending dose [SAD] study)
      and will progress to Part B (multiple ascending dose [MAD] study), and Part C (POC study)
    

Intervention name(s): Part A; Part B; Part C
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Randomized, double-blind, placebo-controlled dose escalation part to investigate the safety, tolerability, immunogenicity, and PK of CDX-7108 after single oral dose administration in healthy adult subjects.
Single-dose administration of CDX-7108 at the following anticipated dose levels. 10 000, 50 000, 150 000, 250 000, and 500 000 lipase units will be evaluated in 5 sequential cohorts of 6 subjects each.; Randomized, double-blind, placebo-controlled dose escalation parts to investigate the safety, tolerability, immunogenicity, and PK of CDX-7108 after multiple oral dose administration in healthy adult subjects.
It will evaluate multiple dose administration of CDX-7108 at an appropriate low (50 000 lipase units), mid (150 000 lipase units), and high dose (250 000 lipase units) 4 times a day (QID) for 6 consecutive days in 3 sequential cohorts of 6 subjects each.; Randomized, double-blind, placebo-controlled, single-dose, 2-way crossover part to assess POC of CDX-7108 in terms of PD as well as its safety, tolerability, and immunogenicity in subjects with EPI.
Approximately 10 subjects with severe EPI from partial/total pancreatectomy or chronic pancreatitis will be enrolled. It is anticipated that Part C (POC study) will commence after completion of the third single-dose cohort from Part A (SAD study) and following SRC review of the data from this cohort.
Other intervention name(s): Single Ascending Dose Study; Multiple Ascending Dose Study; Proof-of-Concept Study
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 3-part study Parts A and B are randomized, double-blind, placebo-controlled dose escalation parts to investigate the safety, tolerability, immunogenicity, and PK of CDX-7108 after single and multiple oral dose administration in healthy adult subjects. Part C is a randomized, double-blind, placebo-controlled, single-dose, 2-way crossover part to assess POC of CDX-7108 in terms of PD as well as its safety, tolerability, and immunogenicity in subjects with EPI.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment