New sickle cell drug candidate tested in healthy volunteers
NCT ID NCT06581627
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This completed Phase 1 study tested a single dose of the drug etavopivat in 24 healthy Chinese adults. Researchers measured how much of the drug got into the blood and how long it stayed, as well as any side effects. The goal was to gather basic safety and drug-processing information to support future studies in people with sickle cell disease or thalassemia.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- etavopivat
- What this could lead to
- If successful, this study could help determine the right dose of etavopivat for future trials in people with sickle cell disease or thalassemia.
- What could go wrong
- This is a very early, small study in healthy volunteers, not patients. It only looks at how the drug moves through the body, not whether it works for any disease.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
24 people
The number who actually took part.
- Started
-
Aug 2024
- Finished
-
Oct 2024
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 45 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Male or female Chinese participants. * Age 18-45 years (both inclusive) at the time of signing the informed consent form. * Body mass index (BMI) between 18.0 and 33.0 kg/m\^2 (both inclusive) at screening. * Body weight greater than or equal to 40.0 kg at screening. * Considered to be generally healthy based on the medical history, physical examination and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator. Exclusion Criteria: * Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive methods. * Participation (i.e., signed informed consent) in any other interventional clinical study within 90 days or 5 times the half-life of the previous investigational medical product (IMP) (if known), whichever is longer before screening. * Any disorder, unwillingness or inability, which in the investigator's opinion might jeopardise the participant's safety or compliance with the protocol. * Use of any medication with unknown or unspecified content within 90 days before screening. * Use of prescription medicinal products or non-prescription drugs (including Chinese traditional medicine or local medicine) within 14 days before screening, as declared by the participant, apart from: * Acceptable contraceptive methods * Hormone replacement therapy (for menopausal females) * Over-the-counter topical medications known to not reach systemic circulation * Occasional use of: * Acetaminophen up to 2 grams (g) (4 x 0.5 g) daily * Ibuprofen up to 2.4 g (4 x 0.6 g) daily * Acetylsalicylic acid up to 2.4 g (4 x 0.6 g) daily * Is unable to refrain from or anticipates the use of any drug known to be a strong or moderate inhibitor or inducer of uridine 5'-diphospho glucuronosyltransferase (UGT) enzymes, cytochrome P450 (CYP) 3A4, CYP2C9 or permeability glycoproteins (P-gp), including St. John's Wort, for 28 days prior to dosing and throughout the study * Is unable to refrain from or anticipates the use of any medications or substances prohibited in the study * Use of tobacco and nicotine products, defined as any of the following: * Has used any product containing tobacco or nicotine within 90 days prior to screening * Not willing to refrain from the use of any product containing tobacco or nicotine throughout the study * Positive nicotine test at screening
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Beijing Hospital
Beijing, Beijing Municipality, 100730, China
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Other studies related to the condition(s) this trial covers.
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