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
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Sep 2020
Longer than P75 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 16, 2020
CompletedFirst Posted
Study publicly available on registry
August 26, 2020
CompletedStudy Start
First participant enrolled
September 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 13, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 13, 2021
CompletedNovember 10, 2022
November 1, 2022
11 months
July 16, 2020
November 7, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With TEAEs
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.
up to 71days (90 days for Cohorts 1 and 2)
Secondary Outcomes (2)
PK
up to 71days (90 days for Cohorts 1 and 2)
Incidence of immunogenicity
up to 71days (90 days for Cohorts 1 and 2)
Study Arms (5)
Cohort 1
EXPERIMENTAL611 dose 1 (45mg) plus placebo
Cohort 2
EXPERIMENTAL611 dose 2 (150mg) plus placebo
Cohort 3
EXPERIMENTAL611 dose 3 (300mg) plus placebo
Cohort 4
EXPERIMENTAL611 dose 4 (450mg) plus placebo
Cohort 5
EXPERIMENTAL611 dose 5 (600mg) plus placebo
Interventions
Eligibility Criteria
You may qualify if:
- Able to understand and willing to sign the ICF
- Healthy male and female subjects, non-smokers, 18-55 years of age
- In the opinion of the investigator, with no significant medical history, and in good health.
- Body mass index 19.0-32.0 kg/m2 and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females.
- Subjects are able to follow the study protocol and complete the trial.
You may not qualify if:
- History of hypersensitivity to similar drugs to 611 or their excipients.
- Pregnant, or nursing females.
- HepBsAg or HepCAb positive.
- Human immunodeficiency virus (HIV) positive.
- Positive urine drug screen, or cotinine test.
- Any reason which, in the opinion of the Qualified Investigator, would prevent the subject from participating in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Covance Dallas Clinical Research Unit
Dallas, Texas, 75247, United States
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2020
First Posted
August 26, 2020
Study Start
September 9, 2020
Primary Completion
August 13, 2021
Study Completion
August 13, 2021
Last Updated
November 10, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share