NCT06679998 - A Phase I Clinical Trial Evaluating the Safety, Tolerability and Pharmacokinetics of AAPB for Injection | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

November 14, 2024

Primary Completion Date

January 12, 2026

Study Completion Date

March 26, 2026

Conditions

Acute Ischemic Stroke (AIS)

Interventions

DRUG

Single dose, AAPB by injection, intravenous drip.

Subjects received a single intravenous infusion of AAPB for injection. Each dose of AAPB for injection was dissolved with 0.9% sodium chloride injection, the infusion volume was 100mL, once a day, and each time was continuously injected for 60 min±5min.

OTHER

Single dose, placebo, intravenous drip.

Subjects received a single intravenous infusion of placebo. Each dose of placebo was dissolved by 0.9% sodium chloride injection with an infusion volume of 100mL once a day for 60 min±5min each time.

DRUG

Multiple dosing, AAPB for injection, intravenous drip

Subjects received AAPB for injection with multiple intravenous drips. Each dose of AAPB for injection was dissolved with 0.9% sodium chloride injection, the infusion volume was 100mL, once a day, 60 min±5min each time, for 7 consecutive days.

OTHER

Multiple dosing, placebo, IV drip

Subjects received multiple intravenous doses of placebo. Each dose of placebo was dissolved by 0.9% sodium chloride injection with an infusion volume of 100mL once a day for 60 min±5min each time for 7 consecutive days.

Trial Locations (1)

100000

Beijing Tiantan Hospital, Capital Medical University, Beijing