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OSE-127

Phase 1

Healthy Subjects | Small molecule | Other |Tango Therapeutics, Inc.|Last Updated: Dec 12, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker

Total Trials1

Total Enrollment63

FDA Designations

No designations recorded

Clinical trial landscape

OSE-127 · 1 trial · 1 indication

Phase 1 1

NCT03980080Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of OSE-127 in Healthy SubjectsHealthy Subjects

COMPLETED63 Analytics

PHASE1COMPLETED

Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of OSE-127 in Healthy Subjects

Healthy Subjects

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Study Endpoints

Primary Endpoints

Part 1 (SAD) & Part 2 (MAD) : Number of Participants With Treatment Emergent Adverse Events (TEAEs)

12 weeks (for Part 1); 19 weeks (for Part 2)

Part 1 (SAD) & Part 2 (MAD) : Number of Participants With Clinically Significant Findings in Physical Examinations Reported as Adverse Event

12 weeks (for Part 1); 19 weeks (for Part 2)

Part 1 (SAD) & Part 2 (MAD) : Number of Participants With Clinically Significant Change in Clinical Laboratory Results Reported as Adverse Event

12 weeks (for Part 1); 19 weeks (for Part 2)

Part 1 (SAD) & Part 2 (MAD) :Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Reported as Adverse Event

12 weeks (for Part 1); 19 weeks (for Part 2)

Part 1 (SAD) & Part 2 (MAD) :Number of Participants With Clinically Significant Change in vital signs Reported as Adverse Event

12 weeks (for Part 1); 19 weeks (for Part 2)

Part 1 (SAD) & Part 2 (MAD) :Number of Participants With Clinically Significant Findings in Telemetry Reported as Adverse Event

12 weeks (for Part 1); 19 weeks (for Part 2)

Part 1 (SAD) & Part 2 (MAD) : Incidence of anti-drug antibody (ADA) formation

12 weeks (for Part 1); 19 weeks (for Part 2)

Secondary Endpoints

Part 1 (SAD) & Part 2 (MAD) : Maximum Plasma Concentration [Cmax]

12 weeks (for Part 1); 19 weeks (for Part 2)

Part 1 (SAD) & Part 2 (MAD) : Average serum Concentration over the dosing interval [Cavg]

12 weeks (for Part 1); 19 weeks (for Part 2)

Part 1 (SAD) & Part 2 (MAD) : Trough serum Concentration observed at the end of the dosing interval [Ctrough]

12 weeks (for Part 1); 19 weeks (for Part 2)

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Study Design & Arms

AllocationRANDOMIZED

MaskingDOUBLE

ModelPARALLEL

PurposeTREATMENT

Treatment Arms

Arm	Type	Description
OSE-127: Part 1 (SAD), Cohort A & Cohort B	EXPERIMENTAL	-
Placebo: Part 1 (SAD), Cohort A & Cohort B	PLACEBO_COMPARATOR	-
OSE-127: Part 2 (MAD)	EXPERIMENTAL	-
Placebo: Part 2 (MAD)	PLACEBO_COMPARATOR	-

Interventions

Name	Type	Description
OSE-127	DRUG	mAb antagonist to CD127 receptor (or IL-7Rα) Group 1-7 6 escalating dose level groups IV SC
Placebo	DRUG	Vehicle study drug

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Eligibility Criteria

Age Range18 Years to 65 Years

SexALL

Healthy VolunteersYes

Study Sites1

Inclusion Criteria: 1. Male or female, aged 18 to 65 years (extremes included). Maximum two subjects aged between 60 and 65 (extremes included) are allowed per dose group. 2. Healthy volunteers (medically stable), as determined on the basis of medical history, vital signs, clinical laboratory testi...

Countries:Belgium

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Frequently asked questions about OSE-127

What is OSE-127 used for?

OSE-127 is an investigational small molecule being studied in healthy subjects. It is being evaluated for safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity in a Phase 1 clinical trial. The drug is not approved for any indication and is still in clinical development.

Who makes OSE-127?

OSE-127 is being developed by Tango Therapeutics, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker TNGX. The company is conducting clinical research on this investigational small molecule in healthy subjects.

What phase is OSE-127 in?

OSE-127 is in Phase 1 clinical development. A Phase 1 study has been completed, evaluating the drug in healthy subjects. The drug is investigational and has not been approved by regulatory authorities for any use.

What clinical trials is OSE-127 in?

OSE-127 has one completed clinical trial, NCT03980080, titled "Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of OSE-127 in Healthy Subjects." The study was conducted in Belgium with 63 participants and was placebo-controlled and double-blind.

Is OSE-127 FDA approved?

OSE-127 is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial in healthy subjects. The drug is still in clinical development and has not been approved for any medical use.