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Also known as Caveolin-1-Scaffolding-Protein-Derived Peptide (LTI-03)
Caveolin-1-Scaffolding-Protein-Derived Peptide · 1 trial · 1 indication
Incidence of TEAE by system-organ class and dose group as assessed by the Toxicity Grading Scale for Healthy Adult Volunteers
| Arm | Type | Description |
|---|---|---|
| Placebo | SHAM_COMPARATOR | Matching placebo is a micronized lactose powder administered by inhalation through a dry powder inhaler (DPI) |
| SAD Cohort 1 | EXPERIMENTAL | LTI-03 20 mg delivered qd x 1 day via DPI |
| SAD Cohort 2 | EXPERIMENTAL | LTI-03 40 mg delivered qd x 1 day via DPI |
| SAD Cohort 3 | EXPERIMENTAL | LTI-03 80 mg delivered qd x 1 day via DPI |
| MAD Cohort 1 | EXPERIMENTAL | LTI-03 dose at 20mg once daily x 14 days via DPI |
| MAD Cohort 2 | EXPERIMENTAL | LTI-03 dose at 40mg once daily x 14 days via DPI |
| MAD Cohort 3 | EXPERIMENTAL | LTI-03 dose at 2.5 mg once daily x 14 days via DPI |
| MAD Cohort 4 | EXPERIMENTAL | LTI-03 dose at 5 mg once daily x 14 days via DPI |
| MAD Cohort 5 | EXPERIMENTAL | LTI-03 dose at 5 mg twice daily x 14 days via DPI |
| Name | Type | Description |
|---|---|---|
| Caveolin-1-Scaffolding-Protein-Derived Peptide (LTI-03) | DRUG | LTI-03, a Caveolin-1 scaffold protein-derived 7-amino acid peptide to be administered as a dry powder by inhalation through a dry powder inhaler. |
| Placebo | DRUG | Matching placebo is micronized lactose powder administered by inhalation through a dry powder inhaler. |
Inclusion Criteria: 1. Non-smoker (no use of tobacco products within 6 months prior to dosing) with a negative urine cotinine test at Screening or Day -1 2. Age of 18-55 years (inclusive) 3. Body mass index (BMI) of 18 - 30.5 kg/m2 (inclusive) 4. Body weight \> 50 kg 5. Willing and able to provide ...
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Caveolin-1-Scaffolding-Protein-Derived Peptide is being developed for idiopathic pulmonary fibrosis, a progressive scarring disease of the lungs. It is an investigational therapy and has not been approved for any indication. Development is currently at the Phase 1 stage, with a completed Phase 1 study conducted in healthy adult subjects in the United Kingdom.
Rein Therapeutics, Inc. is developing Caveolin-1-Scaffolding-Protein-Derived Peptide. The company trades under the ticker symbol RNTX. The asset is being advanced for idiopathic pulmonary fibrosis within the respiratory therapeutic area.
Caveolin-1-Scaffolding-Protein-Derived Peptide is in Phase 1 development. One Phase 1 trial has been completed, and no trials are currently active. The drug remains investigational and has not received FDA approval for any indication.
Caveolin-1-Scaffolding-Protein-Derived Peptide has been evaluated in one completed Phase 1 trial, NCT04233814, titled a Safety, Tolerability and Pharmacokinetic Study of LTI-03 in Healthy Adult Subjects. The trial enrolled 71 participants in the United Kingdom and was randomized, double-blind, and sham-controlled.
Yes. Caveolin-1-Scaffolding-Protein-Derived Peptide is also known as LTI-03. The two names refer to the same investigational asset being developed by Rein Therapeutics, Inc. for idiopathic pulmonary fibrosis.