Trial Outcomes & Findings for OLP-1002 is Being Studied in the Treatment of Pain. (NCT NCT03760913)

Last Updated: 2021-08-26

Results Overview

Participants were observed for any signs or symptoms of adverse events and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit.

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

116 participants

Primary outcome timeframe

Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.

Results posted on

2021-08-26

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Part A, Single Ascending Dose Placebo: Part A, Single Ascending Dose: Subcutaneous Injection: Placebo	30 ng OLP-1002: Part A, Single Ascending Dose OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 30 ng	120 ng OLP-1002: Part A, Single Ascending Dose OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 120 ng	400 ng OLP-1002: Part A, Single Ascending Dose OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 400 ng	1.2 µg OLP-1002: Part A, Single Ascending Dose OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 1.2 µg	3 µg OLP-1002: Part A, Single Ascending Dose OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 3 µg	6 µg OLP-1002: Part A, Single Ascending Dose OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 6 µg	12 µg OLP-1002: Part A, Single Ascending Dose OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 12 µg	20 µg OLP-1002: Part A, Single Ascending Dose OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 20 µg	40 µg OLP-1002: Part A, Single Ascending Dose OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 40 µg	80 µg OLP-1002: Part A, Single Ascending Dose OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 80 µg	160 µg OLP-1002: Part A, Single Ascending Dose OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 160 µg	5 x Placebo Part B, Multiple Ascending Dose Placebo: Part B, Multiple Ascending Dose: Subcutaneous Injection: Placebo x 5	5 x 2 μg OLP-1002: Part B, Multiple Ascending Dose OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 2 μg	5 x 5 μg OLP-1002: Part B, Multiple Ascending Dose OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 5 μg	5 x 10 μg OLP-1002: Part B, Multiple Ascending Dose OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 10 μg	5 x 20 μg OLP-1002: Part B, Multiple Ascending Dose OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 20 μg	5 x 40 μg OLP-1002: Part B, Multiple Ascending Dose OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 40 μg	5 x 80 μg OLP-1002: Part B, Multiple Ascending Dose OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 80 μg
Overall Study STARTED	17	3	6	3	6	3	6	3	3	6	6	6	12	6	6	6	6	6	6
Overall Study COMPLETED	17	3	6	3	6	3	6	3	3	6	6	6	12	6	6	6	6	6	6
Overall Study NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

OLP-1002 is Being Studied in the Treatment of Pain.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo Part A, Single Ascending Dose n=17 Participants Placebo: Part A, Single Ascending Dose: Subcutaneous Injection: Placebo	30 ng OLP-1002: Part A, Single Ascending Dose n=3 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 30 ng	120 ng OLP-1002: Part A, Single Ascending Dose n=6 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 120 ng	400 ng OLP-1002: Part A, Single Ascending Dose n=3 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 400 ng	1.2 µg OLP-1002: Part A, Single Ascending Dose n=6 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 1.2 µg	3 µg OLP-1002: Part A, Single Ascending Dose n=3 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 3 µg	6 µg OLP-1002: Part A, Single Ascending Dose n=6 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 6 µg	12 µg OLP-1002: Part A, Single Ascending Dose n=3 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 12 µg	20 µg OLP-1002: Part A, Single Ascending Dose n=3 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 20 µg	40 µg OLP-1002: Part A, Single Ascending Dose n=6 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 40 µg	80 µg OLP-1002: Part A, Single Ascending Dose n=6 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 80 µg	160 µg OLP-1002: Part A, Single Ascending Dose n=6 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 160 µg	5 x Placebo Part B, Multiple Ascending Dose n=12 Participants Placebo: Part B, Multiple Ascending Dose: Subcutaneous Injection: Placebo x 5	5 x 2 μg OLP-1002: Part B, Multiple Ascending Dose n=6 Participants OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 2 μg	5 x 5 μg OLP-1002: Part B, Multiple Ascending Dose n=6 Participants OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 5 μg	5 x 10 μg OLP-1002: Part B, Multiple Ascending Dose n=6 Participants OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 10 μg	5 x 20 μg OLP-1002: Part B, Multiple Ascending Dose n=6 Participants OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 20 μg	5 x 40 μg OLP-1002: Part B, Multiple Ascending Dose n=6 Participants OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 40 μg	5 x 80 μg OLP-1002: Part B, Multiple Ascending Dose n=6 Participants OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 80 μg	Total n=116 Participants Total of all reporting groups
Age, Customized	36.2 years STANDARD_DEVIATION 12.25 • n=5 Participants	35.7 years STANDARD_DEVIATION 11.55 • n=7 Participants	36.3 years STANDARD_DEVIATION 10.44 • n=5 Participants	37.0 years STANDARD_DEVIATION 11.27 • n=4 Participants	37.0 years STANDARD_DEVIATION 14.25 • n=21 Participants	44.0 years STANDARD_DEVIATION 12.17 • n=8 Participants	33.8 years STANDARD_DEVIATION 11.97 • n=8 Participants	34.0 years STANDARD_DEVIATION 2.65 • n=24 Participants	52.3 years STANDARD_DEVIATION 6.35 • n=42 Participants	43.7 years STANDARD_DEVIATION 15.25 • n=42 Participants	40.8 years STANDARD_DEVIATION 11.27 • n=42 Participants	43.5 years STANDARD_DEVIATION 12.71 • n=42 Participants	39.7 years STANDARD_DEVIATION 10.75 • n=36 Participants	35.7 years STANDARD_DEVIATION 13.60 • n=36 Participants	34.8 years STANDARD_DEVIATION 13.70 • n=24 Participants	41.0 years STANDARD_DEVIATION 8.72 • n=135 Participants	42.5 years STANDARD_DEVIATION 11.31 • n=136 Participants	37.3 years STANDARD_DEVIATION 15.37 • n=44 Participants	33.3 years STANDARD_DEVIATION 13.92 • n=667 Participants	38.4 years STANDARD_DEVIATION 11.91 • n=12 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	2 Participants n=24 Participants	2 Participants n=42 Participants	2 Participants n=42 Participants	2 Participants n=42 Participants	1 Participants n=42 Participants	4 Participants n=36 Participants	3 Participants n=36 Participants	2 Participants n=24 Participants	3 Participants n=135 Participants	2 Participants n=136 Participants	4 Participants n=44 Participants	1 Participants n=667 Participants	40 Participants n=12 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	4 Participants n=21 Participants	3 Participants n=8 Participants	5 Participants n=8 Participants	1 Participants n=24 Participants	1 Participants n=42 Participants	4 Participants n=42 Participants	4 Participants n=42 Participants	5 Participants n=42 Participants	8 Participants n=36 Participants	3 Participants n=36 Participants	4 Participants n=24 Participants	3 Participants n=135 Participants	4 Participants n=136 Participants	2 Participants n=44 Participants	5 Participants n=667 Participants	76 Participants n=12 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants	1 Participants n=12 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants	3 Participants n=4 Participants	6 Participants n=21 Participants	3 Participants n=8 Participants	6 Participants n=8 Participants	3 Participants n=24 Participants	3 Participants n=42 Participants	5 Participants n=42 Participants	6 Participants n=42 Participants	6 Participants n=42 Participants	12 Participants n=36 Participants	6 Participants n=36 Participants	6 Participants n=24 Participants	6 Participants n=135 Participants	6 Participants n=136 Participants	6 Participants n=44 Participants	6 Participants n=667 Participants	115 Participants n=12 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants	0 Participants n=12 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants	0 Participants n=12 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	1 Participants n=24 Participants	1 Participants n=135 Participants	1 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants	6 Participants n=12 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants	0 Participants n=12 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=36 Participants	1 Participants n=36 Participants	0 Participants n=24 Participants	1 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants	7 Participants n=12 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	3 Participants n=4 Participants	5 Participants n=21 Participants	3 Participants n=8 Participants	5 Participants n=8 Participants	2 Participants n=24 Participants	3 Participants n=42 Participants	5 Participants n=42 Participants	5 Participants n=42 Participants	6 Participants n=42 Participants	11 Participants n=36 Participants	4 Participants n=36 Participants	5 Participants n=24 Participants	4 Participants n=135 Participants	5 Participants n=136 Participants	6 Participants n=44 Participants	6 Participants n=667 Participants	100 Participants n=12 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	1 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants	3 Participants n=12 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants	0 Participants n=12 Participants
Height	175.2 cm STANDARD_DEVIATION 9.00 • n=5 Participants	183.3 cm STANDARD_DEVIATION 12.06 • n=7 Participants	177.3 cm STANDARD_DEVIATION 6.89 • n=5 Participants	177.3 cm STANDARD_DEVIATION 6.51 • n=4 Participants	173.8 cm STANDARD_DEVIATION 8.89 • n=21 Participants	170.0 cm STANDARD_DEVIATION 6.00 • n=8 Participants	174.2 cm STANDARD_DEVIATION 7.99 • n=8 Participants	166.7 cm STANDARD_DEVIATION 3.79 • n=24 Participants	173.0 cm STANDARD_DEVIATION 12.17 • n=42 Participants	172.7 cm STANDARD_DEVIATION 9.31 • n=42 Participants	176.0 cm STANDARD_DEVIATION 15.31 • n=42 Participants	170.0 cm STANDARD_DEVIATION 5.44 • n=42 Participants	177.1 cm STANDARD_DEVIATION 10.59 • n=36 Participants	174.0 cm STANDARD_DEVIATION 12.81 • n=36 Participants	175.3 cm STANDARD_DEVIATION 9.71 • n=24 Participants	167.7 cm STANDARD_DEVIATION 6.65 • n=135 Participants	173.2 cm STANDARD_DEVIATION 6.71 • n=136 Participants	167.7 cm STANDARD_DEVIATION 12.53 • n=44 Participants	176.8 cm STANDARD_DEVIATION 4.31 • n=667 Participants	174.0 cm STANDARD_DEVIATION 9.33 • n=12 Participants
Body Weight	75.74 kg STANDARD_DEVIATION 11.677 • n=5 Participants	77.47 kg STANDARD_DEVIATION 20.400 • n=7 Participants	77.32 kg STANDARD_DEVIATION 9.601 • n=5 Participants	75.33 kg STANDARD_DEVIATION 18.230 • n=4 Participants	70.78 kg STANDARD_DEVIATION 8.725 • n=21 Participants	73.80 kg STANDARD_DEVIATION 0.624 • n=8 Participants	73.17 kg STANDARD_DEVIATION 6.910 • n=8 Participants	66.00 kg STANDARD_DEVIATION 4.513 • n=24 Participants	72.53 kg STANDARD_DEVIATION 11.441 • n=42 Participants	72.72 kg STANDARD_DEVIATION 9.353 • n=42 Participants	76.20 kg STANDARD_DEVIATION 15.517 • n=42 Participants	72.23 kg STANDARD_DEVIATION 9.673 • n=42 Participants	77.61 kg STANDARD_DEVIATION 8.632 • n=36 Participants	73.03 kg STANDARD_DEVIATION 14.719 • n=36 Participants	73.03 kg STANDARD_DEVIATION 14.844 • n=24 Participants	64.08 kg STANDARD_DEVIATION 9.853 • n=135 Participants	70.88 kg STANDARD_DEVIATION 9.658 • n=136 Participants	67.02 kg STANDARD_DEVIATION 13.707 • n=44 Participants	75.65 kg STANDARD_DEVIATION 9.408 • n=667 Participants	73.37 kg STANDARD_DEVIATION 11.061 • n=12 Participants
Body Mass Index	24.54 kg/m^2 STANDARD_DEVIATION 2.410 • n=5 Participants	22.73 kg/m^2 STANDARD_DEVIATION 3.585 • n=7 Participants	24.60 kg/m^2 STANDARD_DEVIATION 2.649 • n=5 Participants	23.73 kg/m^2 STANDARD_DEVIATION 4.136 • n=4 Participants	23.45 kg/m^2 STANDARD_DEVIATION 2.421 • n=21 Participants	25.63 kg/m^2 STANDARD_DEVIATION 2.003 • n=8 Participants	24.10 kg/m^2 STANDARD_DEVIATION 1.439 • n=8 Participants	23.73 kg/m^2 STANDARD_DEVIATION 0.551 • n=24 Participants	24.17 kg/m^2 STANDARD_DEVIATION 2.335 • n=42 Participants	24.43 kg/m^2 STANDARD_DEVIATION 2.942 • n=42 Participants	24.37 kg/m^2 STANDARD_DEVIATION 1.279 • n=42 Participants	24.95 kg/m^2 STANDARD_DEVIATION 2.513 • n=42 Participants	24.73 kg/m^2 STANDARD_DEVIATION 1.512 • n=36 Participants	23.95 kg/m^2 STANDARD_DEVIATION 1.925 • n=36 Participants	23.53 kg/m^2 STANDARD_DEVIATION 2.642 • n=24 Participants	22.70 kg/m^2 STANDARD_DEVIATION 2.321 • n=135 Participants	23.57 kg/m^2 STANDARD_DEVIATION 1.941 • n=136 Participants	23.70 kg/m^2 STANDARD_DEVIATION 2.700 • n=44 Participants	24.18 kg/m^2 STANDARD_DEVIATION 2.780 • n=667 Participants	24.13 kg/m^2 STANDARD_DEVIATION 2.240 • n=12 Participants

PRIMARY outcome

Timeframe: Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.

Population: Safety Population

Outcome measures

Outcome measures
Measure	Placebo Part A, Single Ascending Dose n=17 Participants Placebo: Part A, Single Ascending Dose: Subcutaneous Injection: Placebo	30 ng OLP-1002: Part A, Single Ascending Dose n=3 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 30 ng	120 ng OLP-1002: Part A, Single Ascending Dose n=6 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 120 ng	400 ng OLP-1002: Part A, Single Ascending Dose n=3 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 400 ng	1.2 µg OLP-1002: Part A, Single Ascending Dose n=6 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 1.2 µg	3 µg OLP-1002: Part A, Single Ascending Dose n=3 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 3 µg	6 µg OLP-1002: Part A, Single Ascending Dose n=6 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 6 µg	12 µg OLP-1002: Part A, Single Ascending Dose n=3 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 12 µg	20 µg OLP-1002: Part A, Single Ascending Dose n=3 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 20 µg	40 µg OLP-1002: Part A, Single Ascending Dose n=6 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 40 µg	80 µg OLP-1002: Part A, Single Ascending Dose n=6 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 80 µg	160 µg OLP-1002: Part A, Single Ascending Dose n=6 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 160 µg	5 x Placebo Part B, Multiple Ascending Dose n=12 Participants Placebo: Part B, Multiple Ascending Dose: Subcutaneous Injection: Placebo x 5	5 x 2 μg OLP-1002: Part B, Multiple Ascending Dose n=6 Participants OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 2 μg	5 x 5 μg OLP-1002: Part B, Multiple Ascending Dose n=6 Participants OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 5 μg	5 x 10 μg OLP-1002: Part B, Multiple Ascending Dose n=6 Participants OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 10 μg	5 x 20 μg OLP-1002: Part B, Multiple Ascending Dose n=6 Participants OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 20 μg	5 x 40 μg OLP-1002: Part B, Multiple Ascending Dose n=6 Participants OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 40 μg	5 x 80 μg OLP-1002: Part B, Multiple Ascending Dose n=6 Participants OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 80 μg
Number of Participants With Adverse Events Stratified by Overall and Severity Treatment-emergent adverse events (Overall)	7 Participants	3 Participants	2 Participants	0 Participants	0 Participants	1 Participants	2 Participants	0 Participants	0 Participants	3 Participants	5 Participants	3 Participants	7 Participants	3 Participants	4 Participants	5 Participants	4 Participants	6 Participants	5 Participants
Number of Participants With Adverse Events Stratified by Overall and Severity Mild	6 Participants	3 Participants	2 Participants	0 Participants	0 Participants	1 Participants	2 Participants	0 Participants	0 Participants	2 Participants	5 Participants	3 Participants	7 Participants	3 Participants	4 Participants	4 Participants	3 Participants	6 Participants	5 Participants
Number of Participants With Adverse Events Stratified by Overall and Severity Moderate	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	2 Participants	1 Participants	0 Participants
Number of Participants With Adverse Events Stratified by Overall and Severity Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.

Population: Safety Population

Number of participants who experienced clinically important changes from baseline (the last value recorded prior to first dose) to scheduled timepoints in supine diastolic and systolic blood pressure. Participants were supine for at least 5 minutes before blood pressure measurements. Blood pressure was measured in triplicate and the time of measurement are below: Single ascending dose: Predose, 1, 2, 4, 8, 24 (± 1 hours), and 48 hours posdose Multiple ascending dose: Day 1 (Predose, 1, 2, 4, and 8 hours postdose), Day 2, Day 4 (postdose), Day 5, Day 7 (postdose), Day 9, Day 10 (postdose), Day 12, Day 13 (predose, 1, 2, 4, and 8 hours postdose), and Day 15 No treatment or dose related trends and no clinically significant changes were observed in mean or individual participant supine blood pressure. Supine diastolic blood pressure reference range: 90 to 140 mmHg. Supine systolic blood pressure reference range: 50 to 90 mmHg.

Outcome measures

Outcome measures
Measure	Placebo Part A, Single Ascending Dose n=17 Participants Placebo: Part A, Single Ascending Dose: Subcutaneous Injection: Placebo	30 ng OLP-1002: Part A, Single Ascending Dose n=3 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 30 ng	120 ng OLP-1002: Part A, Single Ascending Dose n=6 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 120 ng	400 ng OLP-1002: Part A, Single Ascending Dose n=3 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 400 ng	1.2 µg OLP-1002: Part A, Single Ascending Dose n=6 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 1.2 µg	3 µg OLP-1002: Part A, Single Ascending Dose n=3 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 3 µg	6 µg OLP-1002: Part A, Single Ascending Dose n=6 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 6 µg	12 µg OLP-1002: Part A, Single Ascending Dose n=3 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 12 µg	20 µg OLP-1002: Part A, Single Ascending Dose n=3 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 20 µg	40 µg OLP-1002: Part A, Single Ascending Dose n=6 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 40 µg	80 µg OLP-1002: Part A, Single Ascending Dose n=6 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 80 µg	160 µg OLP-1002: Part A, Single Ascending Dose n=6 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 160 µg	5 x Placebo Part B, Multiple Ascending Dose n=12 Participants Placebo: Part B, Multiple Ascending Dose: Subcutaneous Injection: Placebo x 5	5 x 2 μg OLP-1002: Part B, Multiple Ascending Dose n=6 Participants OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 2 μg	5 x 5 μg OLP-1002: Part B, Multiple Ascending Dose n=6 Participants OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 5 μg	5 x 10 μg OLP-1002: Part B, Multiple Ascending Dose n=6 Participants OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 10 μg	5 x 20 μg OLP-1002: Part B, Multiple Ascending Dose n=6 Participants OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 20 μg	5 x 40 μg OLP-1002: Part B, Multiple Ascending Dose n=6 Participants OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 40 μg	5 x 80 μg OLP-1002: Part B, Multiple Ascending Dose n=6 Participants OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 80 μg
Number of Participants Who Experienced Clinically Important Changes in Supine Diastolic and Systolic Blood Pressure Diastolic blood pressure (mmHg)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Who Experienced Clinically Important Changes in Supine Diastolic and Systolic Blood Pressure Systolic blood pressure (mmHg)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.

Population: Safety Population

Number of participants who experienced clinically important changes from baseline (the last value recorded prior to first dose) to scheduled timepoints in supine pulse rate. Participants were supine for at least 5 minutes before pulse rate measurements. Pulse rate was measured in triplicate and the time of measurement are below: Single ascending dose: Predose, 1, 2, 4, 8, 24 (± 1 hours), and 48 hours posdose Multiple ascending dose: Day 1 (Predose, 1, 2, 4, and 8 hours postdose), Day 2, Day 4 (postdose), Day 5, Day 7 (postdose), Day 9, Day 10 (postdose), Day 12, Day 13 (predose, 1, 2, 4, and 8 hours postdose), and Day 15 No treatment or dose related trends and no clinically significant changes were observed in mean or individual participant supine pulse rate. Reference range: 40 to 100 beats per minute.

Outcome measures

Outcome measures
Measure	Placebo Part A, Single Ascending Dose n=17 Participants Placebo: Part A, Single Ascending Dose: Subcutaneous Injection: Placebo	30 ng OLP-1002: Part A, Single Ascending Dose n=3 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 30 ng	120 ng OLP-1002: Part A, Single Ascending Dose n=6 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 120 ng	400 ng OLP-1002: Part A, Single Ascending Dose n=3 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 400 ng	1.2 µg OLP-1002: Part A, Single Ascending Dose n=6 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 1.2 µg	3 µg OLP-1002: Part A, Single Ascending Dose n=3 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 3 µg	6 µg OLP-1002: Part A, Single Ascending Dose n=6 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 6 µg	12 µg OLP-1002: Part A, Single Ascending Dose n=3 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 12 µg	20 µg OLP-1002: Part A, Single Ascending Dose n=3 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 20 µg	40 µg OLP-1002: Part A, Single Ascending Dose n=6 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 40 µg	80 µg OLP-1002: Part A, Single Ascending Dose n=6 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 80 µg	160 µg OLP-1002: Part A, Single Ascending Dose n=6 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 160 µg	5 x Placebo Part B, Multiple Ascending Dose n=12 Participants Placebo: Part B, Multiple Ascending Dose: Subcutaneous Injection: Placebo x 5	5 x 2 μg OLP-1002: Part B, Multiple Ascending Dose n=6 Participants OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 2 μg	5 x 5 μg OLP-1002: Part B, Multiple Ascending Dose n=6 Participants OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 5 μg	5 x 10 μg OLP-1002: Part B, Multiple Ascending Dose n=6 Participants OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 10 μg	5 x 20 μg OLP-1002: Part B, Multiple Ascending Dose n=6 Participants OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 20 μg	5 x 40 μg OLP-1002: Part B, Multiple Ascending Dose n=6 Participants OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 40 μg	5 x 80 μg OLP-1002: Part B, Multiple Ascending Dose n=6 Participants OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 80 μg
Number of Participants Who Experienced Clinically Important Changes in Supine Pulse Rate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.

Population: Safety Population

Number of participants who experienced clinically important changes from baseline (the last value recorded prior to first dose) to scheduled timepoints in respiratory rate. Participants were supine for at least 5 minutes before respiratory rate measurements. Respiratory rate was measured in triplicate and the time of measurement are below: Single ascending dose: Predose, 1, 2, 4, 8, 24 (± 1 hours), and 48 hours posdose Multiple ascending dose: Day 1 (Predose, 1, 2, 4, and 8 hours postdose), Day 2, Day 4 (postdose), Day 5, Day 7 (postdose), Day 9, Day 10 (postdose), Day 12, Day 13 (predose, 1, 2, 4, and 8 hours postdose), and Day 15 No treatment or dose related trends and no clinically significant changes were observed in mean or individual participant respiratory rate. Reference range: 10 to 24 breaths per minute.

Outcome measures

Outcome measures
Measure	Placebo Part A, Single Ascending Dose n=17 Participants Placebo: Part A, Single Ascending Dose: Subcutaneous Injection: Placebo	30 ng OLP-1002: Part A, Single Ascending Dose n=3 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 30 ng	120 ng OLP-1002: Part A, Single Ascending Dose n=6 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 120 ng	400 ng OLP-1002: Part A, Single Ascending Dose n=3 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 400 ng	1.2 µg OLP-1002: Part A, Single Ascending Dose n=6 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 1.2 µg	3 µg OLP-1002: Part A, Single Ascending Dose n=3 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 3 µg	6 µg OLP-1002: Part A, Single Ascending Dose n=6 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 6 µg	12 µg OLP-1002: Part A, Single Ascending Dose n=3 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 12 µg	20 µg OLP-1002: Part A, Single Ascending Dose n=3 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 20 µg	40 µg OLP-1002: Part A, Single Ascending Dose n=6 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 40 µg	80 µg OLP-1002: Part A, Single Ascending Dose n=6 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 80 µg	160 µg OLP-1002: Part A, Single Ascending Dose n=6 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 160 µg	5 x Placebo Part B, Multiple Ascending Dose n=12 Participants Placebo: Part B, Multiple Ascending Dose: Subcutaneous Injection: Placebo x 5	5 x 2 μg OLP-1002: Part B, Multiple Ascending Dose n=6 Participants OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 2 μg	5 x 5 μg OLP-1002: Part B, Multiple Ascending Dose n=6 Participants OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 5 μg	5 x 10 μg OLP-1002: Part B, Multiple Ascending Dose n=6 Participants OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 10 μg	5 x 20 μg OLP-1002: Part B, Multiple Ascending Dose n=6 Participants OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 20 μg	5 x 40 μg OLP-1002: Part B, Multiple Ascending Dose n=6 Participants OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 40 μg	5 x 80 μg OLP-1002: Part B, Multiple Ascending Dose n=6 Participants OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 80 μg
Number of Participants Who Experienced Clinically Important Changes in Respiratory Rate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.

Population: Safety Population

Resting 12-lead electrocardiogram parameters were recorded after the participant had been supine and at rest for at least 5 minutes. Baseline: the last value recorded prior to first dose; QTcB: QT interval corrected for heart rate using Bazett's formula; QTcF: QT interval corrected for heart rate using Fridericia's method.

Outcome measures

Outcome measures
Measure	Placebo Part A, Single Ascending Dose n=17 Participants Placebo: Part A, Single Ascending Dose: Subcutaneous Injection: Placebo	30 ng OLP-1002: Part A, Single Ascending Dose n=3 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 30 ng	120 ng OLP-1002: Part A, Single Ascending Dose n=6 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 120 ng	400 ng OLP-1002: Part A, Single Ascending Dose n=3 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 400 ng	1.2 µg OLP-1002: Part A, Single Ascending Dose n=6 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 1.2 µg	3 µg OLP-1002: Part A, Single Ascending Dose n=3 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 3 µg	6 µg OLP-1002: Part A, Single Ascending Dose n=6 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 6 µg	12 µg OLP-1002: Part A, Single Ascending Dose n=3 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 12 µg	20 µg OLP-1002: Part A, Single Ascending Dose n=3 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 20 µg	40 µg OLP-1002: Part A, Single Ascending Dose n=6 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 40 µg	80 µg OLP-1002: Part A, Single Ascending Dose n=6 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 80 µg	160 µg OLP-1002: Part A, Single Ascending Dose n=6 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 160 µg	5 x Placebo Part B, Multiple Ascending Dose n=12 Participants Placebo: Part B, Multiple Ascending Dose: Subcutaneous Injection: Placebo x 5	5 x 2 μg OLP-1002: Part B, Multiple Ascending Dose n=6 Participants OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 2 μg	5 x 5 μg OLP-1002: Part B, Multiple Ascending Dose n=6 Participants OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 5 μg	5 x 10 μg OLP-1002: Part B, Multiple Ascending Dose n=6 Participants OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 10 μg	5 x 20 μg OLP-1002: Part B, Multiple Ascending Dose n=6 Participants OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 20 μg	5 x 40 μg OLP-1002: Part B, Multiple Ascending Dose n=6 Participants OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 40 μg	5 x 80 μg OLP-1002: Part B, Multiple Ascending Dose n=6 Participants OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 80 μg
12-lead Electrocardiogram Parameters Maximum postdose QTcB greater than 450 milliseconds	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
12-lead Electrocardiogram Parameters Maximum increase from baseline in QTcB greater than 30 milliseconds	2 Participants	1 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	1 Participants	3 Participants	2 Participants	2 Participants
12-lead Electrocardiogram Parameters Maximum postdose QTcF greater than 450 milliseconds	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
12-lead Electrocardiogram Parameters Maximum increase from baseline in QTcF greater than 30 milliseconds	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	2 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.

Population: Safety Population

Number of participants with findings of clinical importance in clinical chemistry, hematology, and urinalysis test results. Clinical laboratory evaluations included: Clinical chemistry: Alanine aminotransferase; Albumin; Alkaline phosphatase; Aspartate aminotransferase; Calcium; Chloride; Cholesterol; Creatinine; Direct bilirubin; Gamma-glutamyl transferase; Glucose; Inorganic phosphate; Potassium; Sodium; Total bilirubin; Total protein; Urea Hematology: Hematocrit; Hemoglobin; Mean cell hemoglobin; Mean cell hemoglobin concentration; Mean cell volume; Platelet count; Red blood cell count; White blood cell count; White blood cell differential (Basophils; Eosinophils; Lymphocytes; Monocytes; Neutrophils) Urinalysis: Blood; Glucose; Ketones; pH; Protein; Specific gravity; Urobilinogen; Microscopic examination

Outcome measures

Outcome measures
Measure	Placebo Part A, Single Ascending Dose n=17 Participants Placebo: Part A, Single Ascending Dose: Subcutaneous Injection: Placebo	30 ng OLP-1002: Part A, Single Ascending Dose n=3 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 30 ng	120 ng OLP-1002: Part A, Single Ascending Dose n=6 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 120 ng	400 ng OLP-1002: Part A, Single Ascending Dose n=3 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 400 ng	1.2 µg OLP-1002: Part A, Single Ascending Dose n=6 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 1.2 µg	3 µg OLP-1002: Part A, Single Ascending Dose n=3 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 3 µg	6 µg OLP-1002: Part A, Single Ascending Dose n=6 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 6 µg	12 µg OLP-1002: Part A, Single Ascending Dose n=3 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 12 µg	20 µg OLP-1002: Part A, Single Ascending Dose n=3 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 20 µg	40 µg OLP-1002: Part A, Single Ascending Dose n=6 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 40 µg	80 µg OLP-1002: Part A, Single Ascending Dose n=6 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 80 µg	160 µg OLP-1002: Part A, Single Ascending Dose n=6 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 160 µg	5 x Placebo Part B, Multiple Ascending Dose n=12 Participants Placebo: Part B, Multiple Ascending Dose: Subcutaneous Injection: Placebo x 5	5 x 2 μg OLP-1002: Part B, Multiple Ascending Dose n=6 Participants OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 2 μg	5 x 5 μg OLP-1002: Part B, Multiple Ascending Dose n=6 Participants OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 5 μg	5 x 10 μg OLP-1002: Part B, Multiple Ascending Dose n=6 Participants OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 10 μg	5 x 20 μg OLP-1002: Part B, Multiple Ascending Dose n=6 Participants OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 20 μg	5 x 40 μg OLP-1002: Part B, Multiple Ascending Dose n=6 Participants OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 40 μg	5 x 80 μg OLP-1002: Part B, Multiple Ascending Dose n=6 Participants OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 80 μg
Number of Participants With Findings of Clinical Importance in Clinical Chemistry, Hematology, and Urinalysis Test Results	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.

Population: Safety Population

A full physical examination and symptom-directed physical examinations were performed at specified timepoints.

Outcome measures

Outcome measures
Measure	Placebo Part A, Single Ascending Dose n=17 Participants Placebo: Part A, Single Ascending Dose: Subcutaneous Injection: Placebo	30 ng OLP-1002: Part A, Single Ascending Dose n=3 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 30 ng	120 ng OLP-1002: Part A, Single Ascending Dose n=6 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 120 ng	400 ng OLP-1002: Part A, Single Ascending Dose n=3 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 400 ng	1.2 µg OLP-1002: Part A, Single Ascending Dose n=6 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 1.2 µg	3 µg OLP-1002: Part A, Single Ascending Dose n=3 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 3 µg	6 µg OLP-1002: Part A, Single Ascending Dose n=6 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 6 µg	12 µg OLP-1002: Part A, Single Ascending Dose n=3 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 12 µg	20 µg OLP-1002: Part A, Single Ascending Dose n=3 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 20 µg	40 µg OLP-1002: Part A, Single Ascending Dose n=6 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 40 µg	80 µg OLP-1002: Part A, Single Ascending Dose n=6 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 80 µg	160 µg OLP-1002: Part A, Single Ascending Dose n=6 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 160 µg	5 x Placebo Part B, Multiple Ascending Dose n=12 Participants Placebo: Part B, Multiple Ascending Dose: Subcutaneous Injection: Placebo x 5	5 x 2 μg OLP-1002: Part B, Multiple Ascending Dose n=6 Participants OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 2 μg	5 x 5 μg OLP-1002: Part B, Multiple Ascending Dose n=6 Participants OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 5 μg	5 x 10 μg OLP-1002: Part B, Multiple Ascending Dose n=6 Participants OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 10 μg	5 x 20 μg OLP-1002: Part B, Multiple Ascending Dose n=6 Participants OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 20 μg	5 x 40 μg OLP-1002: Part B, Multiple Ascending Dose n=6 Participants OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 40 μg	5 x 80 μg OLP-1002: Part B, Multiple Ascending Dose n=6 Participants OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 80 μg
Number of Participants With Full and Symptom-Directed Physical Examination Results Gingival swelling (clinically significant, not related to study drug)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Full and Symptom-Directed Physical Examination Results Medical device site rash (clinically significant, not related to study drug)	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Full and Symptom-Directed Physical Examination Results Sunburn (clinically significant, not related to study drug)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Full and Symptom-Directed Physical Examination Results Papule (clinically significant, not related to study drug)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Full and Symptom-Directed Physical Examination Results Tongue ulceration (clinically significant, not related to study drug)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.

Population: Safety Population

Evaluation of the dosing site for the following: Pain: Grade 0 to 4 Redness (assessed by estimating the size of the red patch at the injection site across its widest point): Grade 0: 0-24 mm; Grade 1: 25-50 mm; Grade 2: 51-100 mm; Grade 3: More than 100 mm; Grade 4: Requires medical intervention greater than analgesia Swelling (assessed by estimating the size of the raised area around the injection site across its widest point): Grade 0: 0-24 mm; Grade 1: 25-50 mm and does not interfere with activity; Grade 2: 51-100 mm or interferes with activity; Grade 3: More than 100 mm and prevents daily activity; Grade 4: Requires medical intervention greater than analgesia Tenderness: Grade 0 to 4 Bruising and ulceration were evaluated as present or absent.

Outcome measures

Outcome measures
Measure	Placebo Part A, Single Ascending Dose n=17 Participants Placebo: Part A, Single Ascending Dose: Subcutaneous Injection: Placebo	30 ng OLP-1002: Part A, Single Ascending Dose n=3 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 30 ng	120 ng OLP-1002: Part A, Single Ascending Dose n=6 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 120 ng	400 ng OLP-1002: Part A, Single Ascending Dose n=3 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 400 ng	1.2 µg OLP-1002: Part A, Single Ascending Dose n=6 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 1.2 µg	3 µg OLP-1002: Part A, Single Ascending Dose n=3 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 3 µg	6 µg OLP-1002: Part A, Single Ascending Dose n=6 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 6 µg	12 µg OLP-1002: Part A, Single Ascending Dose n=3 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 12 µg	20 µg OLP-1002: Part A, Single Ascending Dose n=3 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 20 µg	40 µg OLP-1002: Part A, Single Ascending Dose n=6 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 40 µg	80 µg OLP-1002: Part A, Single Ascending Dose n=6 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 80 µg	160 µg OLP-1002: Part A, Single Ascending Dose n=6 Participants OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 160 µg	5 x Placebo Part B, Multiple Ascending Dose n=12 Participants Placebo: Part B, Multiple Ascending Dose: Subcutaneous Injection: Placebo x 5	5 x 2 μg OLP-1002: Part B, Multiple Ascending Dose n=6 Participants OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 2 μg	5 x 5 μg OLP-1002: Part B, Multiple Ascending Dose n=6 Participants OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 5 μg	5 x 10 μg OLP-1002: Part B, Multiple Ascending Dose n=6 Participants OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 10 μg	5 x 20 μg OLP-1002: Part B, Multiple Ascending Dose n=6 Participants OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 20 μg	5 x 40 μg OLP-1002: Part B, Multiple Ascending Dose n=6 Participants OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 40 μg	5 x 80 μg OLP-1002: Part B, Multiple Ascending Dose n=6 Participants OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 80 μg
Number of Participants With Injection Site Assessment Results Tenderness : Grade 1 (mild pain to touch)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Injection Site Assessment Results Tenderness : Grade 2 (moderate pain to touch)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Injection Site Assessment Results Pain : Grade 1 (does not interfere with activity)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Injection Site Assessment Results Pain : Grade 2 (interferes with activity or repeated use of non-narcotic pain reliever)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Injection Site Assessment Results Redness : Grade 1 (25-50 mm)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Injection Site Assessment Results Redness : Grade 2 (51-100 mm)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Injection Site Assessment Results Swelling : Grade 1 (25-50 mm)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Injection Site Assessment Results Swelling : Grade 2 (51-100 mm or interferes with activity)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Injection Site Assessment Results Bruising : Present	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	3 Participants	1 Participants	0 Participants	3 Participants	1 Participants

PRIMARY outcome

Timeframe: Part A: Day 1 postdose. Part B: Day 1 postdose and Day 13 postdose.

Population: Safety Population. Plasma concentrations of OLP-1002 were not analyzed for the groups receiving single doses of 30 ng, 120 ng, 400 ng, 1.2 µg, and 3 µg OLP-1002 and were assumed also to be below the lower limit of quantification/limit of detection. Day 13 assessments were not applicable for Part A of the study.

Participants were assessed to demonstrate that exposure to OLP-1002 did not exceed pre-defined exposure limits from non-clinical studies. Participants with temporary detected plasma concentrations between the low limit of detection \[0.2 ng/mL\] and lower limit of quantification \[1 ng/mL\] are presented in the results.