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Lead
HemaQuest Pharmaceuticals Inc.
Age
12–60
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Established diagnosis of SCD
Males and females between 12 and 60 years of age, inclusive
At least 3 episodes of a SCD-related crisis or complication in the 3 years prior to screening OR 1 episode of acute chest syndrome in the 5 years prior to screening
If receiving hydroxyurea, must be receiving a stable dose for at least 6 months prior to screening
If hydroxyurea treatment has been discontinued, at least 3 months have elapsed since last dose
If transfusion in the 4 months prior to screening, then HbA level \< 20% at screening
Average of the initial two HbF levels ≥ 2.0 % within ≤ 7 days prior to the initial dose of HQK-1001. The two must be obtained ≥ 24 hours apart
Ability to swallow tablets
Able and willing to give informed consent and assent (if applicable)
If subject is a woman of child-bearing potential (WCBP), she must have a negative serum pregnancy test within 7 days of first dose of HQK-1001
If a subject is a WCBP, she must agree to use an effective form of contraception within 7 days of the initial dose of HQK-1001 and for one month after HQK-1001 discontinuation
Sexually active male subjects (with WCBP partners) must agree to use latex condoms or ensure that their partner(s) use an effective form of contraception
In the view of the Investigator, subject is able and willing to comply with necessary study procedures
You may not be if
More than 4 hospitalizations for acute sickle cell related events in the previous 12 months prior to screening
Pulmonary hypertension requiring oxygen therapy
QTc \> 450 msec (male) or 470 msec (female) on screening ECG (QT corrected by Fridericia's formula)
Assigned to a regular transfusion program
Use of erythropoiesis stimulating agents within 90 days of screening
ALT \> 3x upper limit of normal (ULN)
Serum creatinine \> 1.2 mg/dL
A serious, concurrent illness that would limit ability to complete or comply with the study requirements
An acute vaso-occlusive event within 3 weeks prior to screening
Creatine phosphokinase (CK) \> 20% above the ULN
An acute illness (e.g., febrile, GI, respiratory) within 72 hours prior to screening
History of syncope, clinically significant dysrhythmias or resuscitation from sudden death
Chronic opiate use, which, in the view of the Investigator, could confound evaluation of an investigational drug
Current abuse of alcohol or drugs
Received another investigational agent within 4 weeks or 5 half-lives, whichever is longer, prior to screening
Currently pregnant or breast feeding a child
Known infection with HIV-1
Infection with hepatitis B or hepatitis C, such that patients are currently on therapy or will be placed on therapy during the trial
Clareo Health | A Study of HQK-1001 in Patients With Sickle Cell Disease
