Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers

A Phase 1 Randomized, Double Blinded, Placebo-Controlled Single Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of 611 in Adult Healthy Male and Female Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04527718

Enrollment

Registered

2020-08-26

Start date

2020-09-09

Completion date

2021-08-13

Last updated

2022-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

This is a Phase 1 randomized, double blinded, placebo-controlled, single dose escalation study to evaluate the safety, tolerability, and PK of 611 in healthy volunteers.

Detailed description

Total duration of the study period per subject is about 4 months broken down as follows: The screening period is up to 28 days, one dose treatment, and follow- up period is up to 71±7 days (90±9 days for Cohorts 1 and 2).

Interventions

DRUGPlacebo

placebo as a single SC injection on Day 1;

DRUG611

611 as a single SC injection on Day 1;

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

1. Able to understand and willing to sign the ICF 2. Healthy male and female subjects, non-smokers, 18-55 years of age 3. In the opinion of the investigator, with no significant medical history, and in good health. 4. Body mass index 19.0-32.0 kg/m2 and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females. 5. Subjects are able to follow the study protocol and complete the trial.

Exclusion criteria

1. History of hypersensitivity to similar drugs to 611 or their excipients. 2. Pregnant, or nursing females. 3. HepBsAg or HepCAb positive. 4. Human immunodeficiency virus (HIV) positive. 5. Positive urine drug screen, or cotinine test. 6. Any reason which, in the opinion of the Qualified Investigator, would prevent the subject from participating in the study.

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants With TEAEs	up to 71days (90 days for Cohorts 1 and 2)	Incidence of treatment-emergent adverse events (TEAEs) will be summarized by SOC and PT for each treatment group, and also be summarized by severity and association with the study treatments.

Secondary

Measure	Time frame	Description
PK	up to 71days (90 days for Cohorts 1 and 2)	PK parameters not limit to Cmax
Incidence of immunogenicity	up to 71days (90 days for Cohorts 1 and 2)	ADA, and NAbs if ADA is positive

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026