NCT04505033

A Study of Injection HB0017 in Adult Healthy Volunteers

A Phase I, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HB0017 Following a Single Dose in Adult Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Huabo Biopharm Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

placebo by subcutaneous (SC) administration. Forty subjects (10 subjects per cohort for SC administration) will be randomized and assigned to up to 4 sequential doses cohorts of HB0017 (50 mg, 150 mg, 300 mg and 450 mg) or matching placebo. Each cohort of ten volunteers will be randomly assigned to receive either a single dose of HB0017 or matching placebo at a ratio of 4:1. Starting with the lowest dose, each of the subsequent doses will be administered only if the preceding dose was determined to be safe and well tolerated. The decision to escalate the next dose will be made jointly by the sponsor s medical expert and the investigator based upon review of 15-day blinded safety data prior to dosing each cohort.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	HB0017	HB0017 at 100 mg/mL (1 mL/vial) in 2 mL glass vial with a rubber stopper. HB0017 will be administered in the abdominal area by a subcutaneous injection in the mornings. A maximum volume of 1 mL is injected per site.
DRUG	placebo	A matching injection solution containing a specific volume of normal saline (0.9%, Sodium Chloride Injection USP) and no active substance will be prepared for the subjects who will be assigned to placebo according to the dose schedule.

Timeline

• Start date: 2020-10-02
• Primary completion: 2021-01-02
• Completion: 2021-02-01
• First posted: 2020-08-07
• Last updated: 2021-07-28

Locations

1 site across 1 country: New Zealand

Regulatory

• FDA-regulated drug study