A Phase I/II Study of ITU512 in Healthy Participants and Patients With Sickle Cell Disease

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT06546670
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • ITU512 — DRUG
    ITU512 is an investigational, oral, low molecular weight (LMW) compound.
  • Placebo — DRUG
    An inactive substance that looks like and is given the same way as ITU512. The effect(s) of ITU512 will be evaluated against the placebo. Placebos are designed as a control and to have no real effect.

Study Details

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary food effect of ITU512 as well as the fetal hemoglobin (HbF)-inducing capacity of ITU512. This will be the first evaluation of the potential therapeutic effect of ITU512 in healthy participants and patients with sickle cell disease (SCD).

Key Dates

Start date
Aug 15, 2024
Status verified
Jun 2026
Primary completion
May 1, 2028
Completion
Feb 19, 2030

Study Design

Enrollment
161 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1A
    Part 1A in healthy participants
  • Experimental: Part 1B
    Part 1B in healthy participants
  • Experimental: Part 1C
    Part 1C in healthy participants
  • Experimental: Part 2A
    Part 2A in patients with sickle cell disease
  • Experimental: Part 2B
    Part 2B in patients with sickle cell disease
  • Experimental: Part 2C
    Optional extension in patients with sickle cell disease

Primary Outcome Measure

Part 1A, Part 1B, Part 1C: Incidence of AEs and SAEs [ Time Frame: Up to approximately 60 days ]

Central Contacts

  • Novartis Pharmaceuticals
    1-888-669-6682
    [email protected]
  • Novartis Pharmaceuticals
    +41613241111

Locations (5)

FacilityCityStateZIPSite coordinators
University of Alabama BirminghamBirminghamAlabama35233
Emily Burke
[email protected]
205-975-4020
Julie Kanter-Washko (PRINCIPAL_INVESTIGATOR)
Quotient Sciences Sea ViewMiamiFlorida33126-
Boston Childrens HospitalBostonMassachusetts02215
Nadia Tarhini
[email protected]
617-355-4278
Matthew M Heeney (PRINCIPAL_INVESTIGATOR)
LifespanProvidenceRhode Island02903
Asher Dillman
[email protected]
401-444-5328
Patrick Mc Gann (PRINCIPAL_INVESTIGATOR)
UT Health Science CenterHoustonTexas77030
Eyuel Baherey
[email protected]
Modupe Idowu (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By condition
Sickle cell disease
By research site
University of Alabama Birmingham· Birmingham, ALQuotient Sciences Sea View· Miami, FLBoston Childrens Hospital· Boston, MALifespan· Providence, RIUT Health Science Center· Houston, TX

Related Studies