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ALTB-268

Phase 1

Healthy Volunteers | Monoclonal antibody | Other |Icon Plc|Last Updated: Feb 6, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment56

FDA Designations

No designations recorded

Clinical trial landscape

ALTB-268 · 1 trial · 1 indication

Phase 1 1
NCT05723692A First-In-Human SAD and MAD Study to Evaluate the Safety, Tolerability, PK and PD of SC Administered ALTB-268 in Healthy VolunteersHealthy Volunteers
COMPLETED56 Analytics
PHASE1COMPLETED
A First-In-Human SAD and MAD Study to Evaluate the Safety, Tolerability, PK and PD of SC Administered ALTB-268 in Healthy Volunteers
Healthy VolunteersUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of ALTB-268 Treatment-Emergent Adverse Events
through study completion, up to day 120 of the study

Adverse events (AEs) - severity of the AEs will be graded using the most current version of the Common Terminology Criteria for AE (CTCAE) (V5.0) 5-point scale. The relationship between AEs and the study drug will be indicated as related or not related.

Secondary Endpoints

Pharmacokinetics of ALTB-268 AUC (PK) of sc administered ALTB-268 in healthy volunteers.
through study completion, up to day 120 of the study
Pharmacokinetics of ALTB-268 Cmax
through study completion, up to day 120 of the study
Pharmacokinetics of ALTB-268 tmax
through study completion, up to day 120 of the study
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ALTB-268EXPERIMENTALSubcutaneous dose in healthy volunteers
PlaceboPLACEBO_COMPARATORSubcutaneous dose in healthy volunteers

Interventions

NameTypeDescription
ALTB-268BIOLOGICALmonoclonal antibody
PlaceboOTHERformulation buffer
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Written Informed Consent and willingness to comply with the study restrictions. 2. Sex: male or female volunteers. 3. Age: 18 to 55 years, inclusive, at screening. 4. Body mass index (BMI): 18.0 to 32.0 kg/m2, inclusive, at screening. 5. Weight: 50 kg to 110 kg, inclusive, at...

Countries:United States
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Frequently asked questions about ALTB-268

What is ALTB-268?

ALTB-268 is an investigational monoclonal antibody being developed by Icon Plc (ticker: ICLR). It is currently in Phase 1 clinical development and has been studied in healthy volunteers. The drug is administered subcutaneously and is being evaluated for its safety, tolerability, pharmacokinetics, and pharmacodynamics.

What does ALTB-268 target?

The specific molecular target of ALTB-268 has not been disclosed. As a monoclonal antibody, it is designed to bind to a specific protein, but the exact target is not publicly available at this time.

Who makes ALTB-268?

ALTB-268 is being developed by Icon Plc, a company publicly traded under the ticker ICLR. Icon Plc is the sponsor of the clinical trials for this investigational drug.

What phase is ALTB-268 in?

ALTB-268 is in Phase 1 clinical development. It has completed one Phase 1 trial in healthy volunteers. The drug is investigational and has not been approved by regulatory authorities for any indication.

What clinical trials is ALTB-268 in?

ALTB-268 has been studied in one completed Phase 1 trial, identified as NCT05723692. This first-in-human study evaluated single ascending doses and multiple ascending doses of subcutaneously administered ALTB-268 in healthy volunteers in the United States. The trial enrolled 56 participants.

Is ALTB-268 the same as any other drug?

No alternative names for ALTB-268 have been disclosed. The drug is known only by its code name ALTB-268 in clinical trial registries and public information.