The goal of this clinical trial is to test the safety and tolerability of a single ascending dose (SAD) of GB-0669 administered intravenously in adults. The goal of this study is also to measure the blood levels of GB-0669 in the body. Study participants will be assigned to receive the study drug or placebo (the placebo is called saline; it is a liquid like salt water and made to look like the study drug but contains no active ingredient). The study is blinded, which means you and the study doctor will not know whether you are getting the study drug or placebo. Study participants will be assigned to one of 5 cohorts (study groups). Each cohort will have a single ascending dose (SAD). The first two SAD cohorts will have 3 study participants receiving GB-0669 and 3 study participants receiving placebo. The last three SAD cohorts will have 10 study participants receiving GB-0669 and 3 study participants receiving placebo. The SAD cohort dose levels will be as follows: 100 mg, 300 mg, 600 mg, 1200 mg, 2400 mg.
This is a randomized, double-blinded, placebo-controlled first in human (FIH) trial to evaluate the safety, tolerability, and pharmacokinetics of GB-0669 in healthy study participants. The trial is designed to administer the GB-0669 drug product intravenously at 5 single ascending dose (SAD) cohort dose levels. Eligible study participants will be screened and randomized to receive either GB-0669 or placebo in each cohort. The safety of the participants enrolled in this trial will be carefully monitored. There will be an independent safety review committee (iSRC) that will review ongoing safety for this trial and provide recommendations to proceed with the cohorts.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
51
Generate Biomedicines
Somerville, Massachusetts, United States
To assess the safety and tolerability of a single ascending dose of GB-0669 administered intravenously in healthy volunteers
Participant incidence and severity of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and TEAEs leading to discontinuation of study treatment. Clinically significant (CS) changes from baseline in: Clinical laboratory results (hematology, clinical chemistry, coagulation and urinalysis, vital signs, twelve-lead electrocardiograms (ECGs).
Time frame: Day -1 to Day 302
To characterize the maximum concentration (Cmax) of GB-0669 following single doses of GB-0669 administered intravenously in healthy volunteers
The Cmax of GB-0669 following single doses in healthy volunteers will be analyzed
Time frame: Day 1 to Day 302
To characterize the time to peak drug concentration (Tmax) of GB-0669 following single doses of GB-0669 administered intravenously in healthy volunteers
The Tmax of GB-0669 following single doses in healthy volunteers will be analyzed
Time frame: Day 1 to Day 302
To characterize the half-life (t1/2) of GB-0669 following single doses of GB-0669 administered intravenously in healthy volunteers
The t1/2 of GB-0669 following single doses in healthy volunteers will be analyzed
Time frame: Day 1 to Day 302
To characterize the area under the curve to last quantifiable timepoint (AUClast) of GB-0669 following single doses of GB-0669 administered intravenously in healthy volunteers
The AUClast of GB-0669 following single doses in healthy volunteers will be analyzed
Time frame: Day 1 to Day 302
To characterize the volume of distribution (V/F) of GB-0669 following single doses of GB-0669 administered intravenously in healthy volunteers
The V/F of GB-0669 following single doses in healthy volunteers will be analyzed
Time frame: Day 1 to Day 302
To characterize the area under the plasma concentration- time curve (AUC) of GB-0669 following single doses of GB-0669 administered intravenously in healthy volunteers
The AUC of GB-0669 following single doses in healthy volunteers will be analyzed
Time frame: Day 1 to Day 302
To characterize the total body clearance from plasma (CL/F) of GB-0669 following single doses of GB-0669 administered intravenously in healthy volunteers
The CL/F of GB-0669 following single doses in healthy volunteers will be analyzed
Time frame: Day 1 to Day 302
To characterize the area under the plasma concentration-time curve from time zero to infinity (AUCinf) of GB-0669 following single doses of GB-0669 administered intravenously in healthy volunteers
The AUCinf of GB-0669 following single doses in healthy volunteers will be analyzed
Time frame: Day 1 to Day 302
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