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A Phase 1, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics, And Preliminary Efficacy of Single and Multiple Ascending Doses of IB-001 in Healthy Participants and Participants With Chronic Hepatitis B

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This study will examine the safety and tolerability of single and multiple doses of IB-001, and will be conducted in two parts: Part A: SAD study in approximately 60 Healthy Volunteers (HV). Part B: MAD study in approximately 30 adult participants living with Chronic Hepatitis B (CHB).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: t
View:

• Able and willing to provide written informed consent.

• Male or female aged 18 to 70 years.

• Females must not be of childbearing potential OR those who are of childbearing potential must be non-pregnant and non-lactating and willing to use a highly effective method of contraception.

• Males whose partners are of childbearing potential must either be surgically sterile or willing to use a highly effective acceptable method of contraception.

• Non-tattooed, clear injection site suitable for SC injection and monitoring in the opinion of the Investigator.

Locations
Other Locations
New Zealand
New Zealand Clinical Research
RECRUITING
Auckland
Contact Information
Primary
Carey Hwang, MD, PhD
ClinOps@integer.bio
+1 615 491 2553
Backup
Nick Hourguettes
ClinOps@integer.bio
+1 240 656 2820
Time Frame
Start Date: 2026-02-20
Estimated Completion Date: 2027-07-01
Participants
Target number of participants: 90
Treatments
Experimental: Arm 1: IB-001
Participants receive IB-001, administered subcutaneously according to the assigned cohort schedule. In Part A (SAD), participants receive a single ascending dose. In Part B (MAD), participants receive once-weekly dosing for 4 weeks.
Placebo_comparator: Arm 2: Placebo
Participants receiving placebo subcutaneously, following the same dosing schedule as the active arm (single dose in SAD; once-weekly for 4 weeks in MAD).
Related Therapeutic Areas
Sponsors
Leads: IntegerBio

This content was sourced from clinicaltrials.gov

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