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NOT YET RECRUITING
NCT07911982
PHASE1

Safety, Tolerability and Pharmacokinetics of ICP-B161 in Healthy Adults Volunteers

Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

View on ClinicalTrials.gov

Summary

This is a randomized, double-blind, placebo-controlled, ascending dose study. The study will be conducted in 2 parts: a single ascending dose (SAD) part (Part A) followed by a multiple ascending dose (MAD) part (Part B). The decision to escalate between dose levels and proceed to Part B will be based upon review of blinded available safety data by a Safety Review Committee.

Official title: A Phase I, Randomized, Double-blind, Placebo-controlled, Single- and Multiple-ascending-dose Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of ICP-B161 in Healthy Participants

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

88

Start Date

2026-11

Completion Date

2028-06

Last Updated

2026-11-03

Healthy Volunteers

Yes

Interventions

DRUG

ICP-B161 (SC or IV)

Dose escalation in Part A will be conducted in 3 Cohorts (Cohorts 1 to 3). Eight participants will be enrolled in each cohort and randomized to receive either ICP-B161 or placebo (ratio 5:1). ICP-B161 will be administered to Cohort 1 participants at the starting dose of 150 mg sc and increased in each new group. Three nominal dose levels in the range of 150 mg sc to 900 mg iv have been selected for evaluation in Part A. The starting dose level in Part B will be determined by the SRC based on safety and tolerability data obtained in Part A. The dose level and cohorts will only be evaluated in Part B if determined to be safe and tolerable in Part A. Eight participants will be enrolled in each cohort and will be randomized to receive a single dose of either ICP-B161 or placebo (ratio 3:1), day1 and day29.

DRUG

Placebo (SC or IV)

Dose escalation in Part A will be conducted in 3 Cohorts (Cohorts 1 to 3). Eight participants will be enrolled in each cohort and randomized to receive either ICP-B161 or placebo (ratio 5:1). ICP-B161 will be administered to Cohort 1 participants at the starting dose of 150 mg sc and increased in each new group. Three nominal dose levels in the range of 150 mg sc to 900 mg iv have been selected for evaluation in Part A. The starting dose level in Part B will be determined by the SRC based on safety and tolerability data obtained in Part A. The dose level and cohorts will only be evaluated in Part B if determined to be safe and tolerable in Part A. Eight participants will be enrolled in each cohort and will be randomized to receive a single dose of either ICP-B161 or placebo (ratio 3:1), day1 and day29.