Current partner codePEPTIDESDE
NCT04773977·Phase 1·INTERVENTIONAL

Clinical Study of IBI362 in Healthy Chinese Male Subjects

Status

Completed

Phase

Phase 1

Enrollment

24

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

This is a study to evaluate the pharmacokinetic characteristics and safety of IBI362 lyophilized powder and IBI362 liquid formulation in healthy Chinese male subjects.

Full detailed description

Pharmacokinetic;Safety

Interventions

Treatment arms and agents.

DRUG

IBI362 liquid formulation

Administered by subcutaneous injection

DRUG

IBI362 lyophilized powder

Administered by subcutaneous injection

Timeline

From registration to results.

  1. First posted

    Feb 26, 2021

  2. Study start

    Mar 3, 2021

  3. Primary completion

    Mar 9, 2021

  4. Study completion

    Jun 17, 2021

  5. Results posted

    Not reported

  6. Registry updated

    Jul 8, 2021

Outcomes

What the study measures.

Primary outcomes

Evaluate the PK parameters of IBI362 in healthy Chinese male subjects

Time frame · From the first dose of study drug until 8 weeks

Peak Plasma Concentration (Cmax)

Evaluate the PK parameters of IBI362 in healthy Chinese male subjects

Time frame · From the first dose of study drug until 8 weeks

Area under the plasma concentration versus time curve (AUC)

Secondary outcomes

Number of Participants With Adverse Events

Time frame · From the first dose of study drug until 8 weeks

The relationship of each adverse event to the investigational product was assessed by the investigator.

Eligibility

Who can take part.

Minimum age
20 Years
Maximum age
45 Years
Sex
MALE
Healthy volunteers
Yes

Inclusion Criteria: 1. 20 years old≤ Healthy males≤45 years old 2. 19 kilograms per meter squared (kg/m²)≤Body Mass Index≤26 kg/m² 3. Willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff Exclusion Criteria: 1. Subjects who have previously completed or discontinued from this study, or who have used IBI362. 2. Abnormal vital signs and physical examination during the screening period; 3. Having cardiovascular, respiratory, liver, kidney, digestive, endocrine, hematologic, neurological, or muscle degenerative diseases can significantly affect drug absorption, metabolism, or elimination, or participation in the study increases risk or interferes with data interpretation. 4. Have a previous or current mental illness. 5. A family history of medullary thyroid carcinoma or multiple endocrine tumor syndrome type 2. 6. There are other factors judged by the investigators that are not suitable for inclusion in this study.

Study locations

1 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

The Sceond Affiliated Hospital of Nanchang University

Nanchang, China

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

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Put the record in context.

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