Study of BW-50218 in Healthy Participants

Shanghai Argo Biopharmaceutical Co., Ltd.

Status and phase: Enrolling; Phase 1

Conditions: Healthy Participants Study

Treatments: Drug: BW-50218 Injection; Drug: Saline (0.9% NaCl)

Study type: Interventional

Funder types: Industry

Identifiers

NCT07401472

BW-50218-1001

Details and patient eligibility

About

Phase 1, Single Ascending Dose Study of Subcutaneous BW-50218 in Healthy Participants

Full description

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered BW-50218 in Healthy Participants

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Capable of providing written informed consent and complying with all study procedures for the duration of the study.
• Body weight and body mass index (BMI) within a range considered appropriate for study participation by the investigator.
• Female participants must be non-pregnant, non-lactating, and either of non-childbearing potential or using highly effective contraception.
• Male participants with partners of childbearing potential must agree to use effective contraception.

Exclusion criteria

• Any medical condition, recent illness, or laboratory result that, in the investigator's opinion, may increase risk or interfere with participation in the study.
• Recent hospitalization or a significant acute medical event.
• History of cancer or any long-term medical condition that the study doctor considers clinically relevant.
• Clinical laboratory findings outside of range which are deemed clinically significant by the investigator at screening or Day -1.
• Positive test for hepatitis B, hepatitis C, or HIV.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 7 patient groups, including a placebo group

BW-50218 Dose 1

Experimental group

Description:

Single dose of BW-50218 injection (Dose 1).

Treatment:

Drug: BW-50218 Injection

BW-50218 Dose 2

Experimental group

Description:

Single dose of BW-50218 injection (Dose 2).

Treatment:

Drug: BW-50218 Injection

BW-50218 Dose 3

Experimental group

Description:

Single dose of BW-50218 injection (Dose 3).

Treatment:

Drug: BW-50218 Injection

BW-50218 Dose 4

Experimental group

Description:

Single dose of BW-50218 injection (Dose 4).

Treatment:

Drug: BW-50218 Injection

BW-50218 Dose 5

Experimental group

Description:

Single dose of BW-50218 injection (Dose 5).

Treatment:

Drug: BW-50218 Injection

BW-50218 Dose 6

Experimental group

Description:

Single dose of BW-50218 injection (Dose 6).

Treatment:

Drug: BW-50218 Injection

Saline Placebo

Placebo Comparator group

Description:

Single dose of Saline Placebo

Treatment:

Drug: Saline (0.9% NaCl)