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Hadlima

Phase 1

Undisclosed | Small Molecules | Other |Biora Therapeutics, Inc.|Trials Updated: Sep 30, 2026

Hadlima development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Sep 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Hadlima clinical trials

Hadlima · 1 trial · 1 indication

Phase 1 1
NCT07849153An Early Feasibility Study of the BioJet™ Oral Biotherapeutic Delivery System for Administration of Therapeutic Agents in Healthy ParticipantsHealthy Subjects
NOT YET_RECRUITING30 Analytics
PHASE1NOT YET_RECRUITING
An Early Feasibility Study of the BioJet™ Oral Biotherapeutic Delivery System for Administration of Therapeutic Agents in Healthy Participants
Healthy Subjects
NCT0784915330
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Study Endpoints

Primary Endpoints

Incidence of TEAEs
From Day 1 to day 30 (EOT visit)
Incidence of SAEs
From Day 1 to day 30 (EOT visit)
Number of participants with abnormal vital signs
Days 1, 2,3,8,15 and day 30 (EOT visit)
Number of participants with abnormal Physical examination findings
From Day 1 to day 30 (EOT visit)
Number of participants with abnormal ECG readings
Days 1, 2 and Day 3
Number of participants with abnormal Laboratory findings
Days 1,3,8,15 and Day 30 (EOT visit)

Secondary Endpoints

Plasma PK parameters- Cmax (maximum serum concentration)
Days 1,2,3,4,6,8,15 and Day 30 (EOT visit)
Plasma PK parameters- Tmax (time to maximum serum concentration)
Days 1,2,3,4,6,8,15 and Day 30 (EOT visit)
Plasma PK parameters- AUC0-last (area under the concentration-time curve from zero to the last quantifiable concentration)
Days 1,2,3,4,6,8,15 and Day 30 (EOT visit)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Hadlima® Group 1EXPERIMENTAL -
Hadlima® Group 2ACTIVE_COMPARATOR -
Hadlima® Group 3ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Hadlima®DRUGRoute of administration: via BioJet™ device oral capsule Dose: 30 mg
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Body mass index between ≥ 18.0 and ≤ 32.0 kg/m2 and weight ≥ 50 kg * Not pregnant or breastfeeding, or willing to cease breastfeeding. * Woman of childbearing potential (WOCBP) or fertile man agrees to use an acceptable method of contraception from the start of Screening until...

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