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KT-621 for Healthy Participants
Lincoln, NE
Phase 1
Recruiting
Research Sponsored by Kymera Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants aged 19 to 55 years with specified weight and BMI criteria
Be between 18 and 65 years old
Must not have
Clinically relevant surgical history excluding prior appendectomy or cholecystectomy
Acute GI symptoms at Screening or admission to the CRU
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment through the safety follow-up visit on either day 14 (sad) or day 38 (mad)
Summary
"This trial is testing a new drug called KT-621 on healthy adult men and women to see how safe it is, how the body processes it, and how it affects the body at different doses."
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Who is the study for?
This trial is for healthy adults aged 19 to 55 who can follow study procedures and agree to use contraception. Participants must have a normal weight and BMI, no recent substance abuse, no significant health issues or abnormal lab results that could affect the study.Check my eligibility
What is being tested?
The trial tests KT-621, a new drug taken by mouth, against a placebo in healthy people. It aims to understand how safe it is and how the body processes it when given once or multiple times at different doses.See study design
What are the potential side effects?
Since this is a first-in-human study of KT-621, potential side effects are not yet fully known but will be closely monitored throughout the trial. Common side effects may include typical reactions seen with oral medications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 19 and 55 years old and meet the specified weight and BMI criteria.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had surgery in the past, but not for appendix or gallbladder removal.
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I have acute stomach or intestinal symptoms.
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I have previously received KT-621 in this study.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from enrollment through the safety follow-up visit on either day 14 (sad) or day 38 (mad)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment through the safety follow-up visit on either day 14 (sad) or day 38 (mad)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Treatment-emergent potentially clinically significant abnormalities in safety laboratory parameters: coagulation
Treatment-emergent potentially clinically significant abnormalities in safety laboratory parameters: serum chemistry
Treatment-emergent potentially clinically-significant abnormalities in safety laboratory parameters: hematology
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: KT-621Active Control1 Intervention
Each participant receives either a single oral dose (SAD) or multiple oral doses (MAD) of KT-621.
Group II: PlaceboPlacebo Group1 Intervention
Each participant receives either a single oral dose (SAD) or multiple oral doses (MAD) of matched placebo.
Find a Location
Closest Location:Celerion· Lincoln, NE· 722 miles
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Kymera Therapeutics, Inc.Lead Sponsor
7 Previous Clinical Trials
729 Total Patients Enrolled