Phase 1 Study of SL-325 in Healthy Volunteers

Launched by SHATTUCK LABS, INC. ·

Keywords

ClinConnect Summary

This is a first-in-human Phase 1 study of SL-325, a drug that blocks DR3, being tested in healthy adults. The trial uses two parts: a single-dose (SAD) and a multiple-dose (MAD) portion with escalating dose levels. It’s randomized and double-blind, meaning participants are randomly assigned to receive SL-325 or a placebo (normal saline) and neither participants nor researchers know who gets the real drug. About 72 healthy volunteers are expected to participate, in Lincoln, Nebraska, at Celerion, with oversight by a data safety monitoring board and in accordance with FDA rules. The main goal is to learn about safety and how the drug behaves in the body.

To be eligible, adults must be 18–55 years old, have a body mass index between 18 and 32, weigh more than 50 kg, and have healthy lab results. People with significant illnesses, recent smoking or drug/alcohol use, pregnancy, or prior adverse reactions to IV infusions are excluded. If enrolled, you would receive one or more doses of SL-325 or placebo across planned dose levels, with several study visits and blood tests for up to about 75 days after the last dose. Researchers will look at safety and tolerability (any side effects), how high drug levels rise and fall, how long the drug stays in the body, the immune response to the drug (antibodies), and how well SL-325 binds to its target cells. The study is expected to start around September 2025 and finish around July 2026.

Gender

ALL

Eligibility criteria