A Phase 3, Multicenter, Randomized, Double-Masked and Placebo-Controlled Study Evaluating the Efficacy and Safety of 0.25% HL036 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye
Phase: PHASE3
Conditions: Dry Eye
Sponsor: HanAll BioPharma Co., Ltd.

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HL036 Ophthalmic Solution 
Clinical Study Protocol HL036-DED-US-P301
Sponsor: HanAll Biopharma, Co., Ltd. 
24 January 2019
Confidential
Page 1

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Clinical Study Protocol HL036-DED-US-P301
Sponsor: HanAll Biopharma, Co., Ltd. 
24 January 2019
Confidential
Page 2

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Clinical Study Protocol HL036-DED-US-P301
Sponsor: HanAll Biopharma, Co., Ltd. 
24 January 2019
Confidential
Page 3

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HL036 Ophthalmic Solution 
Clinical Study Protocol HL036-DED-US-P301
Sponsor: HanAll Biopharma, Co., Ltd. 
24 January 2019
Confidential
Page 4

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HL036 Ophthalmic Solution 
Clinical Study Protocol HL036-DED-US-P301
Sponsor: HanAll Biopharma, Co., Ltd. 
24 January 2019
Confidential
Page 5

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HL036 Ophthalmic Solution 
Clinical Study Protocol HL036-DED-US-P301
Sponsor: HanAll Biopharma, Co., Ltd. 
24 January 2019
Confidential
Page 6

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HL036 Ophthalmic Solution 
Clinical Study Protocol HL036-DED-US-P301
Sponsor: HanAll Biopharma, Co., Ltd. 
24 January 2019
Confidential
Page 7

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HL036 Ophthalmic Solution 
Clinical Study Protocol HL036-DED-US-P301
Sponsor: HanAll Biopharma, Co., Ltd. 
24 January 2019
Confidential
Page 8

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HL036 Ophthalmic Solution 
Clinical Study Protocol HL036-DED-US-P301
Sponsor: HanAll Biopharma, Co., Ltd. 
24 January 2019
Confidential
Page 9

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HL036 Ophthalmic Solution 
Clinical Study Protocol HL036-DED-US-P301
Sponsor: HanAll Biopharma, Co., Ltd. 
24 January 2019
Confidential
Page 10

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Clinical Study Protocol HL036-DED-US-P301
Sponsor: HanAll Biopharma, Co., Ltd. 
24 January 2019
Confidential
Page 11

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Clinical Study Protocol HL036-DED-US-P301
Sponsor: HanAll Biopharma, Co., Ltd. 
24 January 2019
Confidential
Page 12

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Sponsor: HanAll Biopharma, Co., Ltd. 
24 January 2019
Confidential
Page 13

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Clinical Study Protocol HL036-DED-US-P301
Sponsor: HanAll Biopharma, Co., Ltd. 
24 January 2019
Confidential
Page 14

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HL036 Ophthalmic Solution 
Clinical Study Protocol HL036-DED-US-P301
Sponsor: HanAll Biopharma, Co., Ltd. 
24 January 2019
Confidential
Page 15

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HL036 Ophthalmic Solution 
Clinical Study Protocol HL036-DED-US-P301
Sponsor: HanAll Biopharma, Co., Ltd. 
24 January 2019
Confidential
Page 16

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Clinical Study Protocol HL036-DED-US-P301
Sponsor: HanAll Biopharma, Co., Ltd. 
24 January 2019
Confidential
Page 17

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Sponsor: HanAll Biopharma, Co., Ltd. 
24 January 2019
Confidential
Page 18

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Sponsor: HanAll Biopharma, Co., Ltd. 
24 January 2019
Confidential
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Clinical Study Protocol HL036-DED-US-P301
Sponsor: HanAll Biopharma, Co., Ltd. 
24 January 2019
Confidential
Page 20

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HL036 Ophthalmic Solution 
Clinical Study Protocol HL036-DED-US-P301
Sponsor: HanAll Biopharma, Co., Ltd. 
24 January 2019
Confidential
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Clinical Study Protocol HL036-DED-US-P301
Sponsor: HanAll Biopharma, Co., Ltd. 
24 January 2019
Confidential
Page 22

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24 January 2019
Confidential
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24 January 2019
Confidential
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Sponsor: HanAll Biopharma, Co., Ltd. 
24 January 2019
Confidential
Page 25

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24 January 2019
Confidential
Page 26

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24 January 2019
Confidential
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24 January 2019
Confidential
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Confidential
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24 January 2019
Confidential
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Sponsor: HanAll Biopharma, Co., Ltd. 
24 January 2019
Confidential
Page 31

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Sponsor: HanAll Biopharma, Co., Ltd. 
24 January 2019
Confidential
Page 32

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Clinical Study Protocol HL036-DED-US-P301
Sponsor: HanAll Biopharma, Co., Ltd. 
24 January 2019
Confidential
Page 33

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Sponsor: HanAll Biopharma, Co., Ltd. 
24 January 2019
Confidential
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Sponsor: HanAll Biopharma, Co., Ltd. 
24 January 2019
Confidential
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Sponsor: HanAll Biopharma, Co., Ltd. 
24 January 2019
Confidential
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Sponsor: HanAll Biopharma, Co., Ltd. 
24 January 2019
Confidential
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Sponsor: HanAll Biopharma, Co., Ltd. 
24 January 2019
Confidential
Page 38

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24 January 2019
Confidential
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Sponsor: HanAll Biopharma, Co., Ltd. 
24 January 2019
Confidential
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Sponsor: HanAll Biopharma, Co., Ltd. 
24 January 2019
Confidential
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Sponsor: HanAll Biopharma, Co., Ltd. 
24 January 2019
Confidential
Page 42

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HL036 Ophthalmic Solution 
Clinical Study Protocol HL036-DED-US-P301
Sponsor: HanAll Biopharma, Co., Ltd. 
24 January 2019
Confidential
Page 43

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HL036 Ophthalmic Solution 
Clinical Study Protocol HL036-DED-US-P301
Sponsor: HanAll Biopharma, Co., Ltd. 
24 January 2019
Confidential
Page 44

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HL036 Ophthalmic Solution 
Clinical Study Protocol HL036-DED-US-P301
Sponsor: HanAll Biopharma, Co., Ltd. 
24 January 2019
Confidential
Page 45

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HL036 Ophthalmic Solution 
Clinical Study Protocol HL036-DED-US-P301
Sponsor: HanAll Biopharma, Co., Ltd. 
24 January 2019
Confidential
Page 46

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Sponsor: HanAll Biopharma, Co., Ltd. 
24 January 2019
Confidential
Page 47

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HL036 Ophthalmic Solution 
Clinical Study Protocol HL036-DED-US-P301
Sponsor: HanAll Biopharma, Co., Ltd. 
24 January 2019
Confidential
Page 48

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Clinical Study Protocol HL036-DED-US-P301
Sponsor: HanAll Biopharma, Co., Ltd. 
24 January 2019
Confidential
Page 49

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Sponsor: HanAll Biopharma, Co., Ltd. 
24 January 2019
Confidential
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Clinical Study Protocol HL036-DED-US-P301
Sponsor: HanAll Biopharma, Co., Ltd. 
24 January 2019
Confidential
Page 51

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Clinical Study Protocol HL036-DED-US-P301
Sponsor: HanAll Biopharma, Co., Ltd. 
24 January 2019
Confidential
Page 52

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Clinical Study Protocol HL036-DED-US-P301
Sponsor: HanAll Biopharma, Co., Ltd. 
24 January 2019
Confidential
Page 53

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Clinical Study Protocol HL036-DED-US-P301
Sponsor: HanAll Biopharma, Co., Ltd. 
24 January 2019
Confidential
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Clinical Study Protocol HL036-DED-US-P301
Sponsor: HanAll Biopharma, Co., Ltd. 
24 January 2019
Confidential
Page 55

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Clinical Study Protocol HL036-DED-US-P301
Sponsor: HanAll Biopharma, Co., Ltd. 
24 January 2019
Confidential
Page 56

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Sponsor: HanAll Biopharma, Co., Ltd. 
24 January 2019
Confidential
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Sponsor: HanAll Biopharma, Co., Ltd. 
24 January 2019
Confidential
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Sponsor: HanAll Biopharma, Co., Ltd. 
24 January 2019
Confidential
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Sponsor: HanAll Biopharma, Co., Ltd. 
24 January 2019
Confidential
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24 January 2019
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24 January 2019
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24 January 2019
Confidential
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Sponsor: HanAll Biopharma, Co., Ltd. 
24 January 2019
Confidential
Page 69